[Federal Register: July 20, 2004 (Volume 69, Number 138)]
[Page 43425-43426]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0286]

Withdrawal of Six Guidances on the Clinical Evaluation or 
Requirements for Approval of Certain Classes of Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of six guidances on the clinical evaluation or the 
requirements for approval of radiopharmaceuticals, antacids, 
antidiarrheals, laxatives, gastric secretory depressants, and drugs to 
treat superficial bladder cancer. The guidances are being withdrawn 
because they are out of date and of little use to the drug industry. 
The agency has developed other guidances and/or resources to assist the 
industry in obtaining information on the clinical evaluation and the 
requirements for approval of these classes of drugs.

DATES: General comments on agency guidance documents are welcome at any 

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

[[Page 43426]]

electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the 

SUPPLEMENTARY INFORMATION section for electronic access to agency 
guidance documents.

Evaluation and Research (HFD-103), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3139.


I. Withdrawal of Guidances

    FDA is announcing the withdrawal of the following six guidances 
because they are out of date.
    1. Clinical Evaluation of Antidiarrheal Drugs--September 1977
    2. Clinical Evaluation of Gastric Secretory Depressant (GSD) 
Drugs--September 1977
    3. Clinical Evaluation of Antacid Drugs--April 1978
    4. Clinical Evaluation of Laxative Drugs--April 1978
    For information on the topics addressed by the preceding four 
guidances, contact the Division of Gastrointestinal and Coagulation 
Drug Products (HFD-180) in the Center for Drug Evaluation and Research 
    5. Clinical Evaluation of Radiopharmaceutical Drugs--October 1981
    In the Federal Register of June 22, 2004 (69 FR 34683), the agency 
announced the availability of three guidances for industry on 
``Developing Medical Imaging Drug and Biological Products.'' For 
additional information on developing therapeutic radiopharmaceuticals, 
contact the Division of Medical Imaging and Radiopharmaceutical Drug 
Products (HFD-160), CDER.
    6. FDA Requirements for Approval for Drugs to Treat Superficial 
Bladder Cancer--June 1989
    For information on the topic addressed by the preceding guidance, 
contact the Division of Reproductive and Urologic Drug Products (HFD-
580), CDER.

II. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES). Two copies of any 
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. 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 CDER guidance 
documents at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.

    Dated: July 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16477 Filed 7-19-04; 8:45 am]