[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]


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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.

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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those that are outdated or otherwise in need of reform.''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