[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Rules and Regulations]
[Pages 51297-51299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25358]


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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