[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]
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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.
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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]
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