[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)] [Rules and Regulations] [Pages 37682-37683] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-18233] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 801 [Docket No. 95N-310R] RIN 0910-AA54 Revocation of Certain Device Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule to remove certain device regulations that are obsolete or no longer necessary to achieve public health goals. These regulations have been identified for revocation as the result of a page-by-page review of the agency's regulations in response to the administration's ``Reinventing Government'' initiative, which seeks to streamline Government and ease the burden on regulated industry and consumers. EFFECTIVE DATE: August 19, 1996. FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-2974. SUPPLEMENTARY INFORMATION: I. Background On March 4, 1995, President Clinton announced plans for the reform of the Federal regulatory system as part of the administration's ``Reinventing Government'' initiative. In his March 4, 1995, directive, entitled ``Regulatory Reinvention Initiative,''the President ordered all Federal agencies to conduct a page-by-page review of all of their regulations and to ``eliminate or revise [[Page 37683]] those that are outdated or otherwise in need of reform.'' The first results of FDA's efforts in implementing the President's plan were published in the Federal Register of October 13, 1995 (60 FR 53480). That document identified the regulations that FDA was proposing to eliminate, and the Centers within the agency responsible for those regulations. The agency received no comments on the proposed revocation of regulations administered by the Center for Devices and Radiological Health (CDRH). This final rule will finalize the proposed revocation of the following regulations administered by CDRH: II. Section-by-Section Analysis 1. Section 801.403 Specific medical devices; recommended warning and caution statements (21 CFR 801.403). This regulation recommends certain warning and caution statements for: Denture reliners, pads, and cushions; denture repair kits; infrared generators (including heating pads); insulin syringes; mechanical massagers and vibrators; steam or turkish baths; and ultraviolet generators. This section does not contain specific requirements and will therefore be removed from the Code of Federal Regulations (CFR). 2. Section 801.408 Pessaries for intracervical and intrauterine use (21 CFR 801.408). This section contains information that can be more appropriately given as statements of policy and will therefore be removed from the CFR. 3. Section 801.427 Professional and patient labeling for intrauterine contraceptive devices (21 CFR 801.427). This regulation is no longer necessary because these devices are no longer being marketed. If any intrauterine contraceptive devices are approved in the future, the labeling will be approved during the premarket approval process. This regulation will therefore be removed from the CFR. III. Analysis of Impacts FDA has examined the impacts of the final rule under Executive order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 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 final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so 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. Because this final rule removes unnecessary labeling regulations, the agency certifies that the 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. IV. Environmental Impact The agency has determined under 21 CFR 25.24(a)(ii) 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. List of Subjects in 21 CFR Part 801 Labeling, Medical devices, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 801 is amended as follows: PART 801--LABELING 1. The authority citation for 21 CFR part 801 continues to read as follows: Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 357, 360i, 360j, 371, 374). Sec. 801.403 [Removed] 2. Section 801.403 Specific medical devices; recommended warning and caution statements is removed. Sec. 801.408 [Removed] 3. Section 801.408 Pessaries for intracervical and intrauterine use is removed. Sec. 801.427 [Removed] 4. Section 801.427 Professional and patient labeling for intrauterine contraceptive devices is removed. Dated: July 11, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 96-18233 Filed 7-18-96; 8:45 am] BILLING CODE 4160-01-F