[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39096-39097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19319]
[[Page 39096]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0517]
Development of Antimicrobial Drug Products; Development and Use
of FDA Guidance Documents; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER), Office of Drug Evaluation IV (ODE IV),
is providing notice to drug manufacturers regarding its current 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. The agency is requesting public comment on topics for
future guidance development.
DATES: Written comments may be submitted by October 19, 1998. General
comments on agency guidance documents are welcome at any time.
ADDRESSES: Copies of agency guidance documents can be obtained on the
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit
written comments to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD 20852.
Comments are to 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, 9201
Corporate Blvd., Rockville, MD 20850, 301-827-2336.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice explaining its policy for guidance document
development, issuance, and use. The notice included an agency document
entitled ``Good Guidance Practices'' (GGP's), which sets forth agency
policies and procedures for developing, issuing, and using guidance
documents. The GGP's emphasize the importance of gaining public input
early in the guidance development process.
Since the 1970's the agency has issued guidance in a variety of
forms to the pharmaceutical industry to facilitate the development of
antimicrobial drug products. In addition to advice and guidance
provided verbally during various industry and FDA meetings and other
interactions between the regulated industry and FDA, or in individual
letters written to sponsors, general written guidance has also been
provided. In 1977, the agency issued guidance on the development of
antimicrobial drug products entitled ``Clinical Evaluation of Anti-
Infective Drugs (Systemic).'' In fulfillment of a contract from FDA, in
November 1992, the Infectious Disease Society of America (IDSA)
published its ``Guidelines for the Evaluation of Anti-Infective Drug
Products'' in the supplement of ``Clinical Infectious Disease''
(formerly, ``Reviews of Infectious Diseases''). That same month, FDA's
Division of Anti-Infective Drug Products issued ``Points to Consider:
Clinical Development and Labeling of Anti-Infective Drug Products''
(1992) on issues related to evaluating new drug applications for anti-
infective drug products. All of these documents contain information
helpful for designing clinical trial protocols for evaluating the
safety and effectiveness of new therapies to treat infections and
gaining approval for supplemental indications.
In 1996, in an attempt to outline in more detail the elements the
agency considers important when evaluating clinical studies, the agency
initiated efforts to develop guidance that would provide investigators,
academia, and industry with insight on those elements (often referred
to as ``evaluability criteria'') considered important during the
evaluation of clinical studies for antimicrobial drug products. In
March 1997, an early draft guidance, entitled ``Evaluating Clinical
Studies of Antimicrobials in the Division of Anti-Infective Drug
Products,'' was discussed at an Anti-Infective Drug Products Advisory
Committee meeting. That early draft contained an introduction and
individual sections addressing 12 specific indications. Space was
reserved to provide guidance at some later date on approximately 15
additional indications.
Since the 1997 advisory committee meeting, several events have
occurred that affect how clinical trials are designed, conducted,
evaluated, and reported and that are relevant to the revision and
development of guidance on antimicrobial drug products. ODE IV, which
includes the Division of Anti-Infective Drug Products, the Division of
Special Pathogens and Immunologic Drug Products, and the Division of
Anti-Viral Drug Products, reviewed all of its guidance documents and
determined that certain revisions were necessary. In November 1997, the
Food and Drug Administration Modernization Act of 1997 (Modernization
Act) was enacted (Pub. L. 105-115); it contains several provisions
related to drug development and will lead to additional agency guidance
documents on a variety of subjects relating to clinical trial design
and evaluation. For example, section 119 of the Modernization Act
addresses meetings and agreements concerning the design and size of
clinical trials. In addition, in May 1998, the agency published a
guidance for industry entitled ``Providing Clinical Evidence of
Effectiveness for Human Drugs and Biological Products'' (63 FR 27093,
May 15, 1998) that fulfills certain requirements in section 403(b) of
the Modernization Act and that also has implications for antimicrobial
drug products.
ODE IV is continuing its efforts to develop comprehensive guidance
on evaluability criteria by reviewing, updating, consolidating, and
revising its existing guidance documents, taking into account these
broader agency initiatives. Specifically, the office is deciding which
elements of current guidance documents remain applicable, which
elements need to be removed, which elements need to be updated, and
which elements need to be added. In the process, all guidances are
being developed consistent with the agency's GGP's.
Throughout the 1990's, ODE IV has approached the development of
guidance in an open forum as part of its advisory committee process. It
wishes to continue this public and transparent process for guidance
document development. ODE IV generally expects to include advisory
committee review as part of the process of reviewing and developing
guidance for industry on antimicrobial drug development.
II. Guidance Development Plan
ODE IV has reviewed all existing, relevant documents. Within the
next few months, ODE IV expects to issue a general draft guidance that
addresses issues common to all indications and a series of companion
draft guidances that address the following individual indications:
1. Uncomplicated urinary tract infections,
2. Uncomplicated skin and superficial skin structure infections,
3. Complicated skin and soft tissue infections,
4. Community-acquired pneumonia,
5. Nosocomial pneumonia,
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6. Acute bacterial exacerbation of chronic bronchitis,
7. Secondary bacterial infection of acute bronchitis,
8. Acute otitis media,
9. Acute uncomplicated gonorrhea,
10. Acute sinusitus,
11. Complicated urinary tract infections and pyelonephritis,
12. Bacterial prostatitis,
13. Early Lyme disease,
14. Empiric therapy of febrile neutropenia,
15. Vulvovaginal candidiasis,
16. Streptococcal pharyngitis and tonsillitis,
17. Bacterial meningitis, and
18. Bacterial vaginosis.
Key aspects of these draft guidances will be discussed in a July 1998
advisory committee meeting. After the meeting, ODE IV will work toward
finalizing these guidances.
The next step will involve developing draft guidance documents for
the following proposed indications:
1. Nongonoccocal urethritis/cervicitis,
2. Endocarditis,
3. Uncomplicated intra-abdominal infections,
4. Complicated intra-abdominal infections,
5. Gynecologic infections (except sexually transmitted disease and
pelvic inflammatory disease),
6. Pelvic inflammatory disease,
7. Osteomyelitis (acute and chronic),
8. Acute bacterial arthritis, and
9. Helicobacter pylori infections.
Once developed, the agency expects that it will release the guidances
in draft for review and comment, with key elements discussed before the
advisory committee.
ODE IV also is considering developing guidance during the next few
years for the following agents:
1. Agents to treat opportunistic infections related to AIDS;
2. Antimycobacterial agents;
3. Antifungal agents;
4. Antiparasitic agents;
5. Immunologic/transplant agents;
6. Antiviral agents;
7. Dermatologic surgical scrubs, etc.;
8. Agents to treat sepsis/septic shock; and
9. Agents used in surgical prophylaxis.
As with the other guidances, it is expected that these guidances will
first be issued in draft for review and comment and discussed before
the advisory committee.
III. Comments
ODE IV is seeking suggestions and recommendations for future
guidance development. Interested persons may submit comments 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. Received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19319 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F