[Federal Register: May 11, 2005 (Volume 70, Number 90)]
[Notices]               
[Page 24819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my05-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0021]

 
International Conference on Harmonisation; Draft Guidance on Q8 
Pharmaceutical Development; 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 June 
11, 2005, the comment period for the notice, published in the Federal 
Register of February 9, 2005 (70 FR 6888). In the notice, FDA announced 
the availability of a draft guidance entitled ``Q8 Pharmaceutical 
Development.'' FDA is reopening the comment period to provide 
additional time for public comment consistent with the time for comment 
provided by other ICH regulatory entities.

DATES: Submit written or electronic comments on the draft guidance by 
June 11, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written 

requests for single copies of the draft guidance to the Division of 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 the Office of Communication, Training and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send two self-addressed adhesive labels to assist the office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Ajaz Hussain, Center for Drug Evaluation 
and Research (HFD-3), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2847; or Christopher Joneckis, Center for 
Biologics Evaluation and Research (HFM-1), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 9, 2004 (70 FR 6888), FDA 
announced the availability of a draft guidance entitled ``Q8 
Pharmaceutical Development,'' prepared under the auspices of the ICH. 
The draft guidance provides recommendations to sponsors concerning 
pharmaceutical studies as defined in section 3.2.P.2 of module 3 of the 
Common Technical Document (CTD).
    Interested persons were given until April 11, 2005, to submit 
comments on the draft guidance.
    FDA has decided to reopen the comment period on the draft guidance 
until June 11, 2005, to allow the public additional time to review and 
comment on the contents and to be consistent with the time for comment 
provided by other ICH regulatory entities.

II. Comments

    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 are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments are available for public examination in the Division 
of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.


    Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9369 Filed 5-10-05; 8:45 am]

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