[Federal Register: June 1, 2004 (Volume 69, Number 105)]
[Notices]               
[Page 30945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn04-109]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0042]

 
Draft Guidances for Industry on Improving Information About 
Medical Products and Health Conditions; Availability; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
August 10, 2004, the comment period for the draft guidances entitled 
``Brief Summary: Disclosing Risk Information in Consumer-Directed Print 
Advertisements,'' ``Help-Seeking and Other Disease Awareness 
Communications by or on Behalf of Drug and Device Firms,'' and 
``Consumer-Directed Broadcast Advertising of Restricted Devices.'' FDA 
published a notice of availability of the draft guidances in the 
Federal Register of February 10, 2004 (69 FR 6308). FDA is taking this 
action in response to requests for an extension and to allow interested 
parties additional time to submit comments.

DATES: Submit written or electronic comments on the draft guidances by 
August 10, 2004. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidances to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857; or to the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests. Submit written 
comments on the draft guidances to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT:
    Regarding prescription human drugs: Lesley R. Frank, Center for 
Drug Evaluation and Research (HFD-42), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-2831.
    Regarding prescription human biological products: Glenn N. Byrd, 
Center for Biologics Evaluation and Research (HFM-600), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028.
    Regarding medical device products: Deborah Wolf, Center for Devices 
and Radiological Health (HFZ-300), 2098 Gaither Rd., Rockville, MD 
20850, 301-594-4589.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 10, 2004 (69 FR 6308), FDA 
published a document announcing the availability of three draft 
guidance documents entitled ``Brief Summary: Disclosing Risk 
Information in Consumer-Directed Print Advertisements,'' ``Help-Seeking 
and Other Disease Awareness Communications by or on Behalf of Drug and 
Device Firms,'' and ``Consumer-Directed Broadcast Advertising of 
Restricted Devices.'' The draft guidances are intended to provide clear 
advice to medical product firms on how to fulfill the requirements in 
FDA's rules applicable to certain communications to consumers and 
health care professionals.
    In the February 2004 notice of availability, FDA specifically 
requested comments on a number of issues addressed in the draft 
guidances. The agency also requested submission of research and data 
related to these issues. The initial comment period closed on May 10, 
2004. FDA received a request dated April 2, 2004, and numerous requests 
dated May 8, 2004, that the agency extend the comment period. The 
requests cite the need for additional time because of the importance of 
the subject matter to be commented on. The requests also state an 
extension is needed for consultation with interested parties, to 
complete research, and to prepare comments. In response to these 
requests, FDA has decided to reopen the comment period until August 10, 
2004.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written comments on the draft guidance documents by 
August 10, 2004. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. Comments should identify clearly which guidance they are 
commenting on. The draft guidance documents and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Copies of the draft guidances are available on the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines, or http://ww.fda.gov/ohrms/dockets/default.htm.
lt.htm.

    Dated: May 25, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12270 Filed 5-28-04; 8:45 am]

BILLING CODE 4160-01-S