[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Rules and Regulations]
[Page 66636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28522]



[[Page 66636]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 808 and 820

[Docket No. 00N-1561]


Exemption From Federal Preemption of State and Local Cigarette 
and Smokeless Tobacco Requirements; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is revoking its 
regulation governing the exemption from Federal preemption of State and 
local medical device requirements for the sale and distribution of 
cigarettes and smokeless tobacco to children and adolescents. This 
action is being taken in response to the Supreme Court Decision of 
March 21, 2000, in which the court held that Congress has not given FDA 
the authority to regulate tobacco products as customarily marketed. On 
March 31, 2000, FDA removed its regulations restricting the sale and 
distribution of cigarettes and smokeless tobacco to children and 
adolescents. Because these regulations are not in effect, the State 
requirements are not preempted. Therefore, FDA is revoking its 
regulations exempting the State and local requirements from preemption. 
This rule is also adding a regulation that was inadvertently removed in 
a previous document.

DATES: This rule is effective November 7, 2000.

FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2970.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1996 
(61 FR 44398), FDA issued a final regulation restricting the sale and 
distribution of cigarettes and smokeless tobacco to children and 
adolescents. In the Federal Register of November 28, 1997 (62 FR 
63271), FDA issued a final rule granting exemption from preemption 
under section 521 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360k) for certain cigarette and smokeless tobacco 
requirements in Alabama, Alaska, and Utah. These requirements were 
preempted under section 521 of the act because they were different from 
FDA's requirements but they could be exempted because they were more 
stringent than FDA's requirements.
    On March 21, 2000, in Food and Drug Administration vs. Brown & 
Williamson Tobacco Corp., et al., the Supreme Court ruled that Congress 
has not granted FDA jurisdiction to regulate tobacco products as 
customarily marketed. In accordance with this ruling, the agency issued 
a final rule in the Federal Register of March 31, 2000 (65 FR 17135), 
removing its regulations restricting the sale and distribution of 
cigarettes and smokeless tobacco to children and adolescents. The 
agency inadvertently failed to remove the regulations granting 
exemptions from Federal preemption for these three States. Because the 
FDA regulations are not in effect, the State requirements are not 
preempted and may remain in effect. The agency also inadvertently 
removed Sec. 820.1(e) (21 CFR 820.1(e)) (65 FR 17135). Section 820.1(e) 
did not relate to tobacco. Therefore, it is being added in this rule.

List of Subjects

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 820

      

    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 parts 
808 and 820 are amended as follows:

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS

    1. The authority citation for 21 CFR part 808 continues to read as 
follows:

    Authority: 21 U.S.C. 360j, 360k, 371.


Sec. 808.51  [Removed]

    2. Remove Sec. 808.51.


Sec. 808.52  [Removed]

    3. Remove Sec. 808.52.


Sec. 808.94  [Removed]

    4. Remove Sec. 808.94.

PART 820--QUALITY SYSTEM REGULATION

    5. The authority citation for 21 CFR part 820 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383.

    6. Section 820.1 is amended by adding paragraph (e) to read as 
follows:


Sec. 820.1  Scope.

* * * * *
    (e) Exemptions or variances. (1) Any person who wishes to petition 
for an exemption or variance from any device quality system requirement 
is subject to the requirements of section 520(f)(2) of the act. 
Petitions for an exemption or variance shall be submitted according to 
the procedures set forth in Sec. 10.30 of this chapter, the FDA's 
administrative procedures. Guidance is available from the Center for 
Devices and Radiological Health, Division of Small Manufacturers 
Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., 
telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818.
    (2) FDA may initiate and grant a variance from any device quality 
system requirement when the agency determines that such variance is in 
the best interest of the public health. Such variance will remain in 
effect only so long as there remains a public health need for the 
device and the device would not likely be made sufficiently available 
without the variance.

    Dated: October 30, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-28522 Filed 11-6-00; 8:45 am]
BILLING CODE 4160-01-F