[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Rules and Regulations]
[Pages 66105-66106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 805

[Docket No. 85N-0322]


Medical Devices; Revocation of Cardiac Pacemaker Registry

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 revoke a regulation requiring a cardiac pacemaker registry. The 
registry, which was mandated by the Deficit Reduction Act of 1984, 
requires any physician and any provider of services who requests or 
receives Medicare payment for an implantation, removal, or replacement 
of permanent cardiac pacemaker devices and pacemaker leads to submit 
certain information to the registry. The information is used by FDA to 
track the performance of permanent cardiac pacemakers and pacemaker 
leads and by the Health Care Finance Administration (HCFA) to 
administer its Medicare payment program for these devices. This action 
is being taken to implement an act to Repeal An Unnecessary Medical 
Device Reporting Requirement passed by Congress in 1996 to remove the 
cardiac pacemaker registry to eliminate duplicative and unnecessary 
reporting.

DATES:  This regulation is effective December 27, 1999.

FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices 
and Radiological Health (HFZ-342), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2970.
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 23, 1987 (52 FR 27756), FDA and 
HCFA jointly issued a final rule to establish a national cardiac 
pacemaker registry as mandated by the Deficit Reduction Act of 1984 
(Public Law 98-369). The new law, which was enacted on July 18, 1984, 
amended title XVIII of the Social Security Act, by adding section 
1862(h) (42 U.S.C. 1395y(h)) to the Social Security Act . FDA and HCFA 
jointly issued a proposed rule announcing the establishment of this 
registry in the Federal Register of May 6, 1986 (51 FR 16792).
    The final rule for the cardiac pacemaker registry was codified in 
part 805 (21 CFR part 805). Briefly summarized, the scope of the 
regulation provides that FDA establish a nationwide registry for 
cardiac pacemakers and pacemaker leads. FDA used the information 
submitted to the registry to track the performance of permanent 
pacemakers and pacemaker leads and to perform studies and analysis 
regarding the use of the devices. The agency transmitted data to the 
HCFA to administer its Medicare program and to other Federal components 
to carry out statutory responsibilities.
     On October 2, 1996, an act to Repeal An Unnecessary Medical Device 
Reporting Requirement (Public Law 104-224), which amended title XVIII 
of the Social Security Act (42 U.S.C. 1395), became law. The purpose of 
the new law was to remove section 1862(h) (42 U.S.C. 1395y(h)) of the 
Social Security Act to eliminate duplicative and unnecessary reporting.
    When section 1862(h) was added to the Social Security Act, there 
was a need to identify and keep track of defective pacemakers. In 
particular, there was a need to identify circumstances in which a 
defective pacemaker was surgically implanted in a patient, and then 
surgically removed, with both procedures being paid for by Medicare. 
One of the main reasons for this early pacemaker registry was that 
there was no good way to track defective implantable medical devices, 
and no viable way for HCFA to recover costs in those circumstances 
where a defective product was used. Congress enacted an act to repeal 
section 1862(h) of the Social Security Act because the SMDA of 1990 
(Public Law 101-629) added section 519(e) to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i(e)), which requires among other things 
that manufacturers track and collect data for certain devices, 
including permanently implanted pacemakers and pacemaker leads from the 
manufacturer through the distribution chain to the patient using the 
device.
    Notice and comment rulemaking on the revocation of part 805 is 
unnecessary. The statutory authority for this rule has been revoked. 
Therefore, FDA concludes under 5 U.S.C. 553(b)(8) and 21 CFR 
10.40(e)(1), that there is a good cause for revoking part 805 without 
notice and comment rulemaking.

II. Environmental Impact

    The agency 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

[[Page 66106]]

nor an environmental impact statement is required.

III. Analysis of Impact

    FDA has examined the impacts of the final rule under Executive 
Order 12866, and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Reform Act of 1995 (Public 
Law 104-4)). Executive Order 12866 directs agencies to assess all costs 
and benefits of available 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. The final 
rule removes the medical device regulation requiring a national cardiac 
pacemaker registry from part 805. The agency certifies, under the 
Regulatory Flexibility Act, 5 U.S.C. 605(b), that this final rule will 
not have a significant economic impact on a substantial number of small 
entities. In addition, this final rule will not impose expenditures of 
$100 million or more on either the private sector or State, local, and 
tribal governments in the aggregate and, therefore, a written statement 
under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

IV. Paperwork Reduction Act of 1995

    FDA concludes that this 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 
(Public Law 104-13).

List of Subjects in 21 CFR Part 805

    Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
authority of Public Law 104-224, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR Chapter 1 is amended as follows:

PART 805--CARDIAC PACEMAKER REGISTRY

    1. Part 805 is removed.

    Dated: November 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30570 Filed 11-23-99; 8:45 am]
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