E8-20370. Over the Counter Cough and Cold Medication for Pediatric Use; Notice of Public Hearing; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public hearing; request for comments; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice that published in the Federal Register on August 25, 2008 (73 FR 50033). The notice announced a public hearing to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Due to some confusion regarding electronic registration, this notice revises the electronic registration procedures, and corrects the address for the contact person.

DATES:

The correction is effective September 2, 2008.

FOR FURTHER INFORMATION CONTACT:

Faith Dugan, Food and Drug Administration, 10903 New Hampshire Ave., rm. 6182, Silver Spring, MD 20993, 301-796-3446, [e-mail].

SUPPLEMENTARY INFORMATION:

In FR Doc. E8-19657, published on August 25, 2008 (73 FR 50033), the following correction is made to ADDRESSES:

1. On page 50033, in the first and second columns, the ADDRESSES section is corrected to read as follows:

ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

E-mail electronic registration to: [e-mail]. Anyone who has already registered via http://www.regulations.gov does not have to re-register. The agency will accept those registrations.

Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document.

Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the hearing.

For Registration to Attend and/or Participate in the Hearing: Seating at the hearing is limited. People interested in attending should submit electronic registration to Faith Dugan by close of business on September 15, 2008. Registration is free and will be on a first-come, first-served basis. Written or electronic comments will be accepted until December 2, 2008.

If you wish to make an oral presentation at the hearing, you must state your intention on your registration submission (see ADDRESSES). To speak, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. FDA has included questions for comment in section II of this document. You should also identify by number each question you wish to address in your presentation. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.

If you need special accommodations because of a disability, please inform Faith Dugan, (see For Information on the Hearing Contact).

For Information on the Hearing Contact: Faith Dugan, Food and Drug Administration, 10903 New Hampshire Ave., rm. 6182, Silver Spring, MD 20993 , 301-796-3446, FAX: [phone], e-mail: [e-mail].

Dated: August 27, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.