[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Notices]
[Pages 18251-18252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7290]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Development of Animal Models of Pregnancy To Address Medical 
Countermeasures for Influenza in the ``At Risk'' Population of Pregnant 
Women: Influenza as a Case Study; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration's (FDA) Center for Drug Evaluation 
and Research and FDA's National Center for Toxicological Research are 
announcing a 2-day public workshop entitled ``Development of Animal 
Models of Pregnancy To Address Medical Countermeasures for Influenza in 
the `At Risk' Population of Pregnant Women: Influenza as a Case 
Study.'' The purpose of this workshop is to provide a forum to 
carefully consider scientific issues related to selecting animal models 
for use in evaluating medical influenza countermeasures (anti-influenza 
drugs) that may be given during pregnancy. Specifically, this workshop 
will address experimental design issues in selecting the most 
appropriate animal model that mimics human pregnancy. The goal is to 
use this model to evaluate how pregnancy changes the pharmacokinetics 
of anti-influenza drugs in animals and compare those changes to the 
changes that are known to occur in human pregnancy. The data obtained 
from using this model may enhance the knowledge base needed to 
extrapolate the effects of pregnancy on other medical countermeasures.

DATES: Date and Time: The public workshop will be held on April 30, 
2012, from 8:30 a.m. to 5 p.m., and on May 1, 2012, from 8:30 a.m. to 5 
p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Central Shared Use (CSU) Bldg. 2, rm. 
2047, Silver Spring, MD 20993-0002. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1, where routine 
security check procedures will be performed, a visitor badge will be 
issued, and an escort will be provided to the meeting room. Government-
issued identification will be needed. For additional information on 
parking and security, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: For questions about the workshop, please contact 
Cindy de Sales, <a href="/cdn-cgi/l/email-protection#02616b6c667b42766772656774676c76712c616d6f"><span class="__cf_email__" data-cfemail="47242e29233e07332237202231222933346924282a">[email protected]</span></a>, 240-316-3207.
    Registration: There is no fee to attend the public workshop, but 
attendees must register in advance. Space is limited, and registration 
will be on a first-come, first-served basis. Persons interested in 
attending this workshop must register online at http://fda.contractmeetings.com before April 16, 2012. Non-U.S. citizens are 
subject to additional security screening, and they should register as 
soon as possible. For those without Internet access, please contact 
Cindy de Sales (see Contact Person) to register. Onsite registration is 
not available.
    If you need special accommodations due to a disability, please 
contact Cindy de Sales (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: During seasonal and pandemic influenza 
outbreaks, pregnant women generally have greater morbidity and 
mortality than other adults. The data from the 2009 H1N1 influenza 
pandemic suggested that pregnant women were at increased risk for 
medical complications. There is limited information regarding the 
efficacy, pharmacokinetics, optimal dosing, and side effects of anti-
influenza drugs that may need to be used during pregnancy. The same is 
true for most drugs to treat diseases due to other infectious agents.
    The anti-influenza drugs have been selected for further study 
because the influenza virus can infect pregnant women, and oseltamivir, 
an anti-

[[Page 18252]]

influenza drug of the neurominadase inhibitor class, was recommended 
for treatment of and/or for prophylaxis in pregnant women during the 
2009 H1N1 influenza pandemic. In addition, two clinical studies 
conducted in pregnant women provide some pharmacokinetic data for 
oseltamivir.
    This workshop is open to all interested parties. The target 
audience includes professionals in the scientific community interested 
in discussing the challenges of evaluating medical countermeasures for 
effective and safe use during pregnancy.
    The workshop will include plenary and breakout sessions on the 
scientific challenges in the development of animal models of pregnancy 
that can be used to address the safety and efficacy of medical 
countermeasures. Broad topics to be covered in the plenary sessions 
include: (1) The physiology and pharmacology of pregnancy as it relates 
to model development; (2) the role of animal models in evaluating 
medical countermeasures, including influenza therapies, that may be 
used during pregnancy; and (3) experimental design considerations. 
Topics of the breakout sessions will include: (1) Animal model 
selection, (2) design of the pharmacokinetic studies, and (3) 
additional issues in experimental design.
    Background information on the public workshop, registration 
information, the agenda, and other relevant information will be posted, 
as it becomes available, on the registration Web site at http://fda.contractmeetings.com.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Send faxed requests to 301-827-9267.

    Dated: March 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7290 Filed 3-26-12; 8:45 am]
BILLING CODE 4160-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>