[Federal Register Volume 71, Number 50 (Wednesday, March 15, 2006)]
[Notices]
[Pages 13410-13411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0004]


Guidance for Industry on Nonclinical Safety Evaluation of Drug or 
Biologic Combinations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Nonclinical Safety 
Evaluation of Drug or Biologic Combinations.'' This guidance provides 
recommendations on nonclinical approaches to support the clinical study 
and approval of fixed-dose combination products (FDCs), co-packaged 
products, and some adjunctive therapies.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-

[[Page 13411]]

240), 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 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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Abigail C. Jacobs, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0174.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nonclinical Safety Evaluation of Drug or Biologic 
Combinations.'' This guidance provides recommendations on nonclinical 
approaches to support the clinical study and approval of FDCs, co-
packaged products, and some adjunctive therapies. The intent of this 
guidance is to delineate general guiding principles.
    In the Federal Register of January 26, 2005 (70 FR 3714), FDA 
announced the availability of a draft guidance entitled ``Nonclinical 
Safety Evaluation of Drug Combinations.'' This notice gave interested 
persons an opportunity to submit comments. As a result of the comments, 
certain sections of this guidance have been reworded to improve 
clarity. Additionally, the following revisions have been made to the 
guidance: (1) The inclusion of combinations of biologics regulated by 
the Center for Drug Evaluation and Research and drugs, (2) a narrowing 
of the description of ``adjunctive therapies'' covered by the guidance, 
and (3) a clarification of the aspects of the developmental 
reproductive toxicology sections.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on nonclinical safety evaluation of drug and 
biologic combinations. 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. 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. The guidance and received 
comments may be seen 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 document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3713 Filed 3-14-06; 8:45 am]
BILLING CODE 4160-01-S