[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Proposed Rules]
[Pages 51322-51324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. 98N-0417]
General Administrative Rulings and Decisions; Amendment to the
Examination and Investigation Sample Requirements; 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
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 proposed rule is a companion to the direct final rule
published elsewhere in this issue of the Federal Register. This action
is part of FDA's continuing effort to achieve the objectives of the
President's ``Reinventing Government'' initiative, and it is intended
to reduce the burden of unnecessary regulations on food, drugs, and
cosmetics without diminishing the protection of the public health.
DATES: Comments must be received on or before December 9, 1998.
ADDRESSES: Submit written comments 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
This proposed rule is a companion to the direct final rule
published in the final rules section of this issue of the Federal
Register. This companion proposed rule will provide the procedural
framework to finalize the rule in the event that the direct final
[[Page 51323]]
rule receives any significant adverse comment and is withdrawn. The
comment period for this companion proposed rule runs concurrently with
the comment period for the direct final rule. Any comments received
under this companion proposed rule will also be considered as comments
regarding the direct final rule. FDA is publishing the direct final
rule because the rule contains a noncontroversial change, and FDA
anticipates that it will receive no significant adverse comment.
A detailed rationale for the rule is set forth in the preamble to
the direct final rule and in section II of this document. If no
significant adverse comment is received in response to the direct final
rule, no further action will be taken related to this proposed rule.
Instead, FDA will 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, 1998. Additional information about FDA's
direct final rulemaking procedures is set forth in a guidance published
in the Federal Register of November 21, 1997 (62 FR 62466).
If timely significant adverse comments regarding the rule are
received, FDA will publish a document withdrawing the direct final rule
within 30 days after the comment period ends. FDA then will proceed to
respond to all of the comments received regarding the rule and, if
appropriate, the rule will be finalized under this proposed rule using
usual notice-and-comment procedures.
This action is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiative,
and it is intended to reduce the burden of unnecessary regulations on
food, drugs, and cosmetics without diminishing the protection of the
public health.
II. Examination and Investigation Samples
Section 2.10 (21 CFR 2.10) regulates the examination and
investigation samples and sets out provisions related to the collection
of an official sample for FDA's analysis. FDA investigators routinely
collect the samples and pay 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 Sec. 2.10(b)(2) was
established in 1955 as Sec. 1.700(b)(2) (21 CFR 1.700(b)(2)) and
published in the Federal Register of December 20, 1955 (20 FR 9525 at
9539). Section 1.700 was reorganized and republished as Sec. 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.
III. 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.
IV. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of the proposed 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). FDA believes that this
proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. This proposed 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 proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
B. Regulatory Flexibility Analysis
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 proposed rule will
not have a significant economic impact on a substantial number of small
entities. Therefore, under the Regulatory Flexibility Act, no further
analysis is required.
C. Unfunded Mandates Reform Act of 1995
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 proposed 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 proposed rule.
V. 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.
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 proposed rule. Two copies of any comments are to be
submitted, except that individuals may submit one copy.
[[Page 51324]]
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. All
comments received will be considered as comments regarding the direct
final rule. In the event the direct final rule is withdrawn, all
comments received regarding the direct final rule and this companion
proposed rule will be considered under this proposed rule.
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, 21 CFR part
2 is proposed to be 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. 98-25359 Filed 9-24-98; 8:45 am]
BILLING CODE 4160-01-F