[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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