[Federal Register Volume 62, Number 33 (Wednesday, February 19, 1997)]
[Proposed Rules]
[Page 7395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4046]


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 808

[Docket No. 96N-0249]
RIN 0910-AB03


Medical Devices; Opportunity for Oral Hearing on Proposed Action 
on Applications for Exemption From Preemption From Cigarette and 
Smokeless Tobacco Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity for oral hearing.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for interested persons to request an oral hearing on a 
proposed rule that would grant exemption from Federal preemption for 
certain cigarette and smokeless tobacco requirements in various States. 
The proposed rule is published elsewhere in this issue of the Federal 
Register.

DATES: Requests for an oral hearing by March 21, 1997.

ADDRESSES: Written requests to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Anne M. Kirchner, Office of Policy 
(HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-5321.

SUPPLEMENTARY INFORMATION: FDA's regulation in Sec. 808.25 (21 CFR 
808.25) provides procedures for processing applications for exemption 
from Federal preemption of State and local requirements applicable to 
medical devices under section 521 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360k). Section 808.25(c) provides 
that, when FDA issues in the Federal Register a proposed rule either to 
grant or to deny a request for exemption from preemption, the agency 
will also issue in the Federal Register a notice of opportunity for 
interested persons to request an oral hearing before FDA to present 
views on the application and the proposed rule.
    Elsewhere in this issue of the Federal Register, FDA is issuing a 
proposed rule responding to the following applications for exemption 
from preemption:
    (1) An application from the State of Alabama for exemption from 
preemption for section 13A-12-3 of the Alabama Code;
    (2) An application from the State of Alaska for exemption from 
preemption for sections 11.76.100 and 11.76.105 of the Alaska Statutes;
    (3) An application from the State of Utah for exemption from 
preemption for section 76-10-104 of the Utah Code Annotated; and
    (4) An application from the State of Washington for exemption from 
preemption for section 26.28.080 of the Revised Code of Washington and 
for section 314-10-050 of the Washington Administrative Code.
Therefore, in accordance with Sec. 808.25(c), FDA is announcing an 
opportunity for interested persons to request an oral hearing on its 
proposal to grant exemption from Federal preemption for certain State 
requirements pertaining to cigarettes and smokeless tobacco.
    FDA advises that, under Sec. 808.25(d), any request for a hearing 
is required to be submitted to the Dockets Management Branch (address 
above) and to include an explanation of why an oral hearing, rather 
than submission of written comments only, is essential to the 
presentation of views on the application for exemption from preemption 
and on the proposed regulation. Further, to ensure expeditious review 
of requests for an oral hearing and final action on the applications 
for exemption and on the proposed rule, FDA has limited the period for 
requesting an oral hearing to 30 days from the date of publication of 
the proposed rule and this notice in the Federal Register.
    Under Sec. 808.25(e), if a timely request for a hearing is made, 
FDA will review the request and will determine whether a hearing should 
be granted. If FDA determines that an oral hearing should be held, it 
will announce the time, date, and place of the hearing in a future 
issue of the Federal Register. The procedures that will govern any such 
oral hearing are those applicable to a public hearing under part 15 (21 
CFR part 15) of FDA's administrative practices and procedures 
regulations.
    Interested persons may, on or before March 21, 1997, submit to the 
Dockets Management Branch (address above) written requests for an oral 
hearing on this matter. Two copies of any requests are to be submitted, 
except that individuals may submit one copy. Requests are to be 
identified with the docket number found in brackets in the heading of 
this document. Received requests may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under FDA's authority in section 521 of the 
act and under authority delegated to the Commissioner of Food and Drugs 
(21 CFR 5.10).

    Dated: February 7, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-4046 Filed 2-13-97; 2:19 pm]
BILLING CODE 4160-01-F