[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Page 66180-66181]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007N-0356]

Behind the Counter Availability of Certain Drugs; Public Meeting; 
Comment Period Clarification

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; comment period clarification.


SUMMARY:  In the Federal Register of October 4, 2007 (72 FR 56769), the 
Food and Drug Administration (FDA) published a notice that announced a 
public meeting to obtain comments regarding behind-the-counter (BTC) 
availability of human drugs. An incorrect date was published in that 
notice. This document clarifies that Docket No. 2007N-0356 will close 
on December 17, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0356, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     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. 

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written registration and comments in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously, in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All comments received may be posted 
without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, 

including any personal information provided. For additional information 
on submitting comments, 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/ohrms/dockets/default.htm 

and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

[[Page 66181]]

    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
 approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT:  Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360, FAX: 301-594-6777 Erik.Mettler@fda.hhs.gov.


I. Background

    In the Federal Register of October 4, 2007 (72 FR 56769), FDA 
announced that it would hold a public meeting regarding BTC 
availability of certain human drugs. BTC availability could make 
certain drugs available behind the counter at the pharmacy without a 
prescription and require the intervention of a pharmacist before 
    Some groups have asserted that pharmacist interaction with the 
consumer could ensure safe and effective use of a drug product that 
otherwise might require a prescription. Because pharmacists have the 
training and knowledge to provide certain interventions, they may be 
able to ensure that patients meet the conditions for use and educate 
patients on appropriate use of the drug product. These groups have 
suggested that the availability of certain drugs BTC could increase 
patient access to medications that may be underutilized, particularly 
by patients without health insurance, because these medications 
otherwise would be available only with a prescription.
    The Federal Register notice stated that interested persons would be 
able to submit comments to the Division of Dockets Management and that 
the public docket would remain open for 30 days following the meeting. 
Our intent was to state that the docket would remain open until 
December 17, 2007 (30 days after the meeting, which occurred on 
November 14, 2007). However, the notice also instructed persons to 
register if they wished to attend or participate in the meeting; the 
instructions stated that registration would occur on a first-come, 
first-serve basis, but then mistakenly declared that written or 
electronic comments would be accepted ``until November 28, 2007'' (72 
FR 56769).

II. Comments

    This notice clarifies that we will accept comments to the public 
docket until December 17, 2007.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

    Dated: November 20, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-23026 Filed 11-26-07; 8:45 am]