[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65750-65751]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no07-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0439]
Draft Guidance for Industry on Smallpox (Variola) Infection:
Developing Drugs for Treatment or Prevention; 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availability of a draft guidance for industry entitled ``Smallpox
(Variola) Infection: Developing Drugs for Treatment or Prevention.'' In
this draft guidance, FDA provides recommendations on the development of
drugs to be used to treat or prevent smallpox (variola) infection. This
guidance is intended to help sponsors plan and design appropriate
studies during the development of these drugs.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 22, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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. Send one self-addressed adhesive label to
assist that office in processing your requests. 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on the draft guidance to the Division of Dockets Management (HFA-305),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://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Debra B. Birnkrant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6332, Silver Spring, MD 20993-0002, 301-
796-1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment
or Prevention.'' This guidance provides recommendations on the
development of drugs to be used to treat or prevent smallpox (variola)
infection. The study of smallpox drug development poses special
challenges in drug development because of the unique attributes of the
pathogen. Therefore, this guidance focuses on the importance of pre-
investigational new drug application interactions between sponsors and
FDA, appropriate approaches to nonclinical studies in early drug
development, generation and use of supporting data from related
poxviruses, design and characterization of animal models, approaches to
clinical trials including safety studies, advance preparation of
protocols for potential use in emergency settings, and use of
combinations of animal and human data.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on developing
drugs to treat or prevent smallpox (variola) infection. 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. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB Control No. 0910-0014.
[[Page 65751]]
III. 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, 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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
IV. 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: November 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22884 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S