[Federal Register: June 24, 2004 (Volume 69, Number 121)]
[Proposed Rules]
[Page 35277-35278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn04-20]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 3
[Docket No. 2004N-0194]
Definition of Primary Mode of Action of a Combination Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending until
August 20, 2004, the comment period on the primary mode of action
proposed rule that appeared in the Federal Register of May 7, 2004 (69
FR 25527). In the primary mode of action proposed rule, the agency
states its intentions to amend the product jurisdiction regulations to
define ``mode of action'' and ``primary mode of action'' (PMOA). Along
with these definitions, the proposed rule sets forth an algorithm the
agency would use to assign combination products to an agency component
for regulatory oversight when the agency cannot determine with
reasonable certainty which mode of action provides the most important
therapeutic action of the combination product. Finally, the proposed
rule would also require a sponsor to base its recommendation of the
agency component with primary jurisdiction for regulatory oversight of
its combination product on the PMOA definition and, if appropriate, the
assignment algorithm. The proposed rule is intended to promote the
public health by codifying the agency's criteria for the assignment of
combination products in transparent, consistent, and predictable terms.
DATES: Submit written or electronic comments no later than August 20,
2004.
ADDRESSES: You may submit comments, identified by Docket 2004N-0194, by
any of the following methods:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
[[Page 35278]]
Follow the instructions for submitting comments on the agency Web
site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0194 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and
Docket No. 2004N-0194 or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch
Way, suite 200, Rockville, MD 20855, 301-427-1934.
SUPPLEMENTARY INFORMATION: FDA issued this proposed rule with an
opportunity for public comment during a 60-day time period beginning
May 7, 2004. On May 18, 2004, FDA received a request from the Advanced
Medical Technology Association (AdvaMed) to extend the comment period
for an additional 60 days for Docket No. 2004N-0194. According to
AdvaMed, the Association needs additional time to advise their members
about the proposed rule, and to collect and organize their members'
input regarding the proposed rule.
Comments
In response to the request from AdvaMed, FDA is extending the
comment period an additional 45 days to close on August 20, 2004. This
extension will provide the public with a total of 105 days to submit
comments. To be timely, interested persons must submit to the Division
of Dockets Management (see ADDRESSES) written or electronic comments on
the proposed rule by August 20, 2004. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14265 Filed 6-23-04; 8:45 am]
BILLING CODE 4160-01-S