04-12270. 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.

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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents.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://www.fda.gov/​cder/​guidance/​index.htm, http://www.fda.gov/​cber/​guidelines, or http://ww.fda.gov/​ohrms/​dockets/​default.htm.

Dated: May 25, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.