[Federal Register Volume 69, Number 121 (Thursday, June 24, 2004)]
[Proposed Rules]
[Pages 35277-35278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14265]


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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://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments.

[[Page 35278]]

 Follow the instructions for submitting comments on the agency Web 
site.
     E-mail: [email protected]. 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://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://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