[Federal Register Volume 63, Number 145 (Wednesday, July 29, 1998)]
[Notices]
[Pages 40532-40533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0548]


Draft Guidances for Industry on the Development of Antimicrobial 
Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.


[[Page 40533]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Office of Drug 
Evaluation IV (ODE IV), Center for Drug Evaluation and Research (CDER), 
is announcing the availability of several draft guidance documents on 
the development of antimicrobial drug products. A general draft 
guidance document entitled ``Developing Antimicrobial Drugs--General 
Considerations for Clinical Trials'' discusses issues common to the 
development of all antimicrobial drugs. The companion draft guidance 
documents address issues related to developing drugs to treat 
individual indications. These draft guidance documents are intended to 
help sponsors design clinical trials that will yield information the 
agency can use to determine whether the antimicrobial drug under study 
is safe and effective in the treatment of the specific infection 
studied. Key elements of these draft guidance documents will be 
discussed at a July 29, 30, and 31, 1998, Anti-Infective Drugs Advisory 
Committee meeting.

DATES: Written comments on the draft guidance documents may be 
submitted by October 27, 1998. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Copies of the draft guidance documents are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of the draft guidance documents to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on the draft 
guidance documents to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Renata Albrecht, Center for Drug 
Evaluation and Research (HFD-590), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2336.

SUPPLEMENTARY INFORMATION: FDA's divisions of Anti-Infective Drug 
Products, Special Pathogens and Immunologic Drug Products, and Anti-
Viral Drug Products in CDER's ODE IV are issuing the first documents in 
a series of draft guidance documents that are intended to assist 
sponsors in designing, carrying out, and analyzing the results of 
clinical trials for the development of antimicrobial drug products. A 
general draft guidance document entitled ``Developing Antimicrobial 
Drugs--General Considerations for Clinical Trials'' discusses issues 
common to all antimicrobial drugs. The companion draft guidance 
documents address issues related to developing drugs to treat 
individual indications. Key elements from these draft guidance 
documents and related issues will be discussed at an Anti-Infective 
Drugs Advisory Committee meeting on July 29, 30, and 31, 1998 (63 FR 
34655, June 25, 1998).
    In the Federal Register of July 21, 1998 (63 FR 39096), ODE IV 
announced its plans for revising existing guidance documents and 
preparing new guidance documents on the development of antimicrobial 
drug products for the treatment of infections. ODE IV is reviewing, 
updating, consolidating, and revising its existing guidance documents 
and identifying topics for future guidance documents. In that notice, 
ODE IV explained its plan and requested public comment on topics for 
future guidance document development. The draft guidance documents are 
a part of ODE IV's guidance development plan.
    The general draft guidance document being made available is 
entitled ``Developing Antimicrobial Drugs--General Considerations for 
Clinical Trials.'' The draft companion guidances are being made 
available on individual indications as follows:
    <bullet> Uncomplicated urinary tract infections,
    <bullet> Uncomplicated and complicated skin and skin structure 
infections,
    <bullet> Community-acquired pneumonia,
    <bullet> Nosocomial pneumonia,
    <bullet> Acute bacterial exacerbation of chronic bronchitis,
    <bullet> Secondary bacterial infection of acute bronchitis,
    <bullet> Acute otitis media,
    <bullet> Acute uncomplicated gonorrhea,
    <bullet> Acute sinusitus,
    <bullet> Complicated urinary tract infections and pyelonephritis,
    <bullet> Bacterial prostatitis,
    <bullet> Early Lyme disease,
    <bullet> Empiric therapy of febrile neutropenia,
    <bullet> Vulvovaginal candidiasis,
    <bullet> Streptococcal pharyngitis and tonsillitis,
    <bullet> Bacterial meningitis, and
    <bullet> Bacterial vaginosis.
Additional guidances are under development.
    The information in these draft guidance documents represents the 
agency's current thinking on developing antimicrobial drug products. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute, 
regulations, or both.
    Interested persons may submit written comments on the draft 
guidance documents to the Dockets Management Branch (address above). 
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. The draft 
guidance documents and received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 23, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20239 Filed 7-28-98; 8:45 am]
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