[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Page 69743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29006]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

The Development and Evaluation of Human Cytomegalovirus Vaccines; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration, Center for Biologics Evaluation 
and Research, the National Institutes of Health, the National Institute 
of Allergy and Infectious Diseases, the Centers for Disease Control and 
Prevention, and the National Vaccine Program Office are announcing a 
public workshop entitled ``The Development and Evaluation of Human 
Cytomegalovirus Vaccines.'' The purpose of the public workshop is to 
identify and discuss key issues related to the development and 
evaluation of human cytomegalovirus (HCMV) vaccines. The public 
workshop will include presentations on HCMV disease and pathogenesis 
and issues related to vaccine development.
    Date and Time: The public workshop will be held on January 10 and 
January 11, 2012, from 8:30 a.m. to 5:30 p.m.
    Location: The public workshop will be held at Lister Hill Center 
Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville 
Pike, Bethesda, MD 20894. Pre-registered participants will receive 
additional information on parking and public transportation with their 
email registration confirmation.
    Contact Person: Manen Bishop, Center for Biologics Evaluation and 
Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, (301) 827-2000, FAX: (301) 827-
3079, email: [email protected] (Subject line: HCMV Vaccine 
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax numbers) to Manen 
Bishop (see Contact Person) or email to [email protected] 
(Subject line: HCMV Workshop Registration) by December 12, 2011. There 
is no registration fee for the public workshop. Early registration is 
recommended because seating is limited. Registration on the day of the 
public workshop will be provided on a space available basis beginning 
at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Manen Bishop (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: HCMV, also known as human herpesvirus 5, 
infects approximately half of the U.S. population by adulthood. While 
most infections are without symptoms, the infection is lifelong. 
However, the disease may become apparent in children who were infected 
during gestation (congenital HCMV) and in infected individuals with 
weakened immune systems. Congenital HCMV infection causes mental 
retardation, learning disabilities, hearing loss, vision loss, and 
other disabilities. Patients undergoing stem cell or solid-organ 
transplants are at particularly high risk for severe disease or death 
from HCMV infection.
    An effective vaccine could have a significant impact on rates of 
congenital anomalies and severe infections caused by HCMV. However, 
efforts to develop a vaccine against HCMV have not yet been successful.
    The public workshop will focus on the status of knowledge about 
HCMV biology and epidemiology and on vaccine development strategies. 
Topics for discussion will include: (1) HCMV epidemiology and 
diagnosis, (2) HCMV immunology and virology, (3) manufacturers' and 
regulators' perspectives, (4) target populations for a HCMV vaccine, 
(5) design of clinical trials to study HCMV vaccines in the setting of 
congenital HCMV and transplants, and (6) next steps toward development 
of HCMV vaccines.
    Transcripts: Please be advised that as soon as possible after a 
transcript of the public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: November 3, 2011.
 Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29006 Filed 11-8-11; 8:45 am]