[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