[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rule receives any significant adverse comment and is withdrawn.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