[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 51298]]
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
[[Page 51299]]
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