Amendment to Examination and Investigation Sample Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. 98N-0417]

Amendment to Examination and Investigation Sample Requirements

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 regarding the collection of twice the quantity of food,

drug, or cosmetic estimated to be sufficient for analysis. This action

increases the dollar amount that FDA will consider to determine whether

to routinely collect a reserve sample of a food, drug, or cosmetic

product in addition to the quantity sufficient for analysis. Experience

has demonstrated that the current dollar amount does not adequately

cover the cost of most quantities sufficient for analysis plus reserve

samples. This direct final rule is part of FDA's continuing effort to

achieve the objectives of the President's ``Reinventing Government''

initiative, and is intended to reduce the burden of unnecessary

regulations on food, drugs, and cosmetics without diminishing the

protection of the public health. Elsewhere in this issue of the Federal

Register, FDA is publishing a companion proposed rule under FDA's usual

procedures for notice and comment to provide a procedural framework to

finalize the rule in the event the agency receives any significant

adverse comment and withdraws this direct final rule.

DATES: This rule is effective February 8, 1999. Comments must be

received on or before December 9, 1998. If FDA receives no significant

adverse comments during the specified comment period, the agency

intends to publish a confirmation document within 30 days after the

comment period ends confirming that the direct final rule will go into

effect on February 8, 1999. If the agency receives any

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significant adverse comment, FDA intends to withdraw this direct final

rule action by publication in the Federal Register within 30 days after

the comment period ends.

ADDRESSES: Submit written comments on the direct final rule to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630

Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sharon M. Sheehan, Office of Regulatory Affairs (HFC-230), Food and

Drug Administration, 12720 Twinbrook Pkwy., Rockville, MD 20855, 301-

827-0412.

SUPPLEMENTARY INFORMATION:

I. Background

Examination and investigation samples (Sec. 2.10 (21 CFR 2.10)),

sets out provisions related to the collection of an official sample for

FDA's analysis. Routinely, the FDA investigator collects the sample and

pays the owner of the regulated food, drug, or cosmetic product either

the regular selling price, or, if acceptable to the owner, the dealer's

invoice cost plus a nominal charge (usually 10 to 15 percent) (see

Investigations Operations Manual, January 1998, ch. 4, section 416.2,

at 129). The regulations require the investigator to collect an extra

amount of the product beyond what is needed for analysis, known as a

reserve sample, to allow for additional analysis (see section 702(b) of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372(b) and

Sec. 2.10(c)). Under most circumstances the investigator is to collect

at least ``twice the quantity estimated by him to be sufficient for

analysis * * *.''

One of the few narrow exceptions to the requirement to collect at

least twice the quantity estimated to be sufficient for analysis is

when the cost of the quantity sufficient for analysis and the reserve

sample together exceeds $50. The decision whether to collect twice the

quantity sufficient for analysis if the cost of that amount exceeds the

regulatory amount (currently $50) is made on a case-by-case basis.

The current regulatory amount as set forth in section 2.10(b)(2)

was established in 1955 as Sec. 1.700(b)(2) (21 CFR 1.700(b)(2))

published in the Federal Register of December 20, 1955 (20 FR 9539).

Section 1.700 was reorganized and republished as section 2.10, and the

regulatory amount was increased from $10 to $50 in 1977 (see 42 FR

15559, March 22, 1977).

A regulatory amount of $150 more accurately reflects an amount that

would cover the cost of most quantities sufficient for analysis plus

reserve samples. The amount of $150 is based, in part, on the Consumer

Price Index (CPI) from the Bureau of Labor and Statistics, Department

of Commerce. In August 1977, the CPI was 61.2; in August 1996, the CPI

was 157.3. This change represents an increase of approximately 157

percent. Therefore, $50 in 1977 is equivalent to approximately $128

today. Considering that the regulatory amount has changed every 20

years, setting the amount at $150 contemplates that another increase

likely will not occur for several years.

II. Rulemaking Action

In the Federal Register of November 21, 1997 (62 FR 62466), FDA

described its procedures on when and how FDA will employ direct final

rulemaking. FDA believes that this rule is appropriate for direct final

rulemaking because FDA views this rule as a noncontroversial amendment

and anticipates no significant adverse comments. Consistent with FDA's

procedures on direct final rulemaking, FDA is publishing elsewhere in

this issue of the Federal Register a companion proposed rule to amend

the existing Sec. 2.10(b)(2). The companion proposed rule provides a

procedural framework within which the rule may be finalized in the

event the direct final rule is withdrawn because of any significant

adverse comment.

The FDA has provided a comment period on the direct final rule of

75 days after September 25, 1998. If the agency receives any

significant adverse comment, FDA intends to withdraw this direct final

rule action by publication in the Federal Register within 30 days after

the comment period ends. 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

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. A comment

recommending a rule change in addition to the rule would not be

considered a significant adverse comment, unless the comment states why

the rule would be ineffective without additional change. In addition,

if a significant adverse comment applies to part of a rule and that

part can be severed from the remainder of the rule, FDA may adopt as

final those parts of the rule that are not the subject of a significant

adverse comment.

If any significant adverse comment is received during the comment

period, FDA will publish, within 30 days after the comment period ends,

a document withdrawing the direct final rule. If FDA withdraws the

direct final rule, all comments received will be considered under the

proposed rule in developing a final rule under the usual Administrative

Procedure Act notice- and-comment procedures.

If FDA receives no significant adverse comments during the

specified comment period. FDA intends to publish a confirmation

document within 30 days after the comment period ends, confirming that

the direct final rule will go into effect on February 8, 1999.

III. Analysis of Impacts

FDA has examined the impacts of the direct final rule under

Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C.

601-612), and under the Unfunded Mandates Reform Act (Pub. L. 104-4).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this direct final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. This direct final rule

increases the dollar limit FDA uses to determine whether a quantity

estimated as twice that which is sufficient for analysis will routinely

be collected. The rule does not adversely affect the owners of foods,

drugs, or cosmetics from which samples are collected. This direct final

rule is not a significant regulatory action as defined by the Executive

Order and is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The agency certifies that this direct final rule

will not have a significant economic impact on a

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substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further regulatory flexibility analysis is

required.

The Unfunded Mandates Reform Act requires that agencies prepare an

assessment of anticipated costs and benefits before proposing any rule

that may result in an annual expenditure by State, local, or tribal

governments, in the aggregate, or by the private sector, of $100

million (adjusted annually for inflation). This direct final rule does

not impose any mandates on State, local, or tribal governments, nor is

it a significant regulatory action under the Unfunded Mandates Reform

Act. Industry will incur no net costs as a result of this direct final

rule.

IV. Paperwork Reduction Act of 1995

This 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. Environmental Impact

FDA 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.

VI. Request for Comments

Interested persons may, on or before December 9, 1998, submit to

the Dockets Management Branch (address above) written comments

regarding this 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 2

Administrative practice and procedure, Cosmetics, Drugs, Foods.

Therefore under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 24 CFR part

2 is amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

1. The authority citation for 21 CFR part 2 continues to read as

follows:

Authority: 21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352,

355, 357, 360b, 361, 371, 372, 374; 15 U.S.C. 402, 409.

2. Section 2.10 is amended by revising paragraph (b)(2) to read as

follows:

Sec. 2.10 Examination and investigation samples.

* * * * *

(b) * * *

(2) The cost of twice the quantity so estimated exceeds $150.

* * * * *

Dated: September 11, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination

[FR Doc. 98-25358 Filed 9-24-98; 8:45 am]

BILLING CODE 4160-01-M