Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps, 66850-66851 [2012-27146]

Download as PDF 66850 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following meeting: ‘‘Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps.’’ An interagency planning committee led by FDA, in collaboration with the Defense Threat Reduction Agency; the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health; the Centers for Disease Control and Prevention; the U.S. Army Medical Research Institute of Infectious Diseases; the Biomedical Advanced Research and Development Authority; the Chemical Biological Medical Systems Joint Project Management Office; the U.S. Strategic Command Center for Combating Weapons of Mass Destruction; and the Joint Science and Technology Office for Chemical and Biological Defense, developed this workshop to present the most current information on melioidosis (caused by Burkholderia pseudomallei) and glanders (caused by B. mallei), with the general purpose of building on information presented at previous meetings and identifying future areas of research needed to advance animal model development and to advance candidate medical countermeasures (MCMs) for approval, licensure, or clearance. SUMMARY: This public workshop will be held on Thursday, November 29, 2012, from 8 a.m. EST to 5 p.m. EST, and Friday, November 30, 2012, from 8 a.m. EST to 12 noon EST. Persons interested in attending the workshop in person or viewing via Webcast must register by Wednesday, November 21, 2012, at 5 p.m. EST. ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click pmangrum on DSK3VPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 15:43 Nov 06, 2012 Jkt 229001 on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. FOR FURTHER INFORMATION CONTACT: Pamela Chamberlain, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4122, 301–796–2968, FAX: 301–847– 8615, email: Pamela.Chamberlain@fda.hhs.gov, Web site: https://www.fda.gov/ medicalcountermeasures. SUPPLEMENTARY INFORMATION: I. Background B. pseudomallei is a gram-negative bacterial pathogen that causes melioidosis, a disease endemic in Southeast Asia and northern Australia. Melioidosis is historically associated with a high mortality rate due to the speed with which septicemia develops and the inherent resistance of the bacteria to several classes of antibiotics. For example, a 20-year prospective study of melioidosis in northern Australia found an overall mortality of 14 percent and a 50 percent mortality rate for patients with septic shock (Ref. 1). A 9-year prospective study of melioidosis in northeast Thailand found an overall mortality rate of 42.6 percent (Ref. 2). Prolonged courses of antibiotics are required to treat melioidosis (Ref. 3). Despite prolonged antimicrobial therapy, recurrent disease is common (at a rate of greater than or equal to 6 percent in the first year) (Refs. 1 and 4). In addition to the public health threat posed by naturally occurring infections, B. pseudomallei has been determined to pose a material threat sufficient to affect the United States’ national security (Ref. 5). B. mallei (formerly Pseudomonas mallei) is a gram-negative, bacterial pathogen that causes glanders and is primarily a zoonotic disease in Africa, Asia, the Middle East, and Central/ South America. Natural glanders infections occur primarily in horses, donkeys, and mules, but most mammals have some degree of susceptibility. While human susceptibility to B. mallei infection has not been studied indepth, the organism is highly infectious in the laboratory setting. Prolonged antimicrobial therapy is required to treat B. mallei infection and prevent its relapse (Refs. 6 and 7). B. mallei has also been determined to pose a material threat sufficient to affect the United States’ national security (Ref. 5). Because of the lengthy antibiotic therapy required to treat melioidosis and glanders and the suboptimal PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 clinical outcomes, lack of vaccines, possible biothreat applications, and public health implications, there is significant interest in developing new MCMs as well as improved animal models to evaluate candidate MCMs for these diseases. This public workshop was designed with specific goals that include, but are not limited to: • Review of the current state of the knowledge of human melioidosis and glanders; • Discussion of the availability of relevant animal models and their current state of development; • Discussion of the availability, development, procurement, and stockpiling of relevant MCMs, including diagnostic tests; and • Identification of the scientific and regulatory considerations associated with testing and development of MCMs for safe and effective treatment or prevention of these diseases. II. How to Register If you wish to attend the public workshop or view via Webcast, you must register at https://www.fda.gov/ medicalcountermeasures by Wednesday, November 21, 2012, at 5 p.m. EST. When registering, you must provide the following information: (1) Your name, (2) title, (3) company or organization (if applicable), (4) mailing address, (5) phone number, and (6) email address. There is no fee to register for the public meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. If you need special accommodations due to a disability, please enter pertinent information in the ‘‘Notes’’ section of the electronic registration form when you register. III. References The following references have been placed on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at https://www.regulations. gov. (FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Currie B.J., L. Ward, and A.C. Cheng, ‘‘The Epidemiology and Clinical Spectrum of Melioidosis: 540 Cases From the 20 Year Darwin Prospective Study,’’ Public Library of Science Neglected Tropical Diseases, vol. 4(11):e900, 2010. E:\FR\FM\07NON1.SGM 07NON1 66851 Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices 2. Limmathurotsakul D., S. Wongratanacheewin, N. Teerawattanasook, et al, ‘‘Increasing Incidence of Human Melioidosis in Northeast Thailand,’’ American Journal of Tropical Medicine and Hygiene, vol. 82(6), pp. 1113–1117, 2010. 3. Wiersinga W.J., B.J. Currie, and S.J. Peacock, ‘‘Melioidosis,’’ The New England Journal of Medicine, vol. 367(11), pp. 1035– 1044, 2012. 4. Limmathurotsakul D., W. Chaowagul, W. Chierakul, et al., ‘‘Risk Factors for Recurrent Melioidosis in Northeast Thailand,’’ Clinical Infectious Diseases, vol. 43(8), pp. 979–986, 2006. 5. U.S. Department of Health and Human Services, ‘‘2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy,’’ (Washington, DC: U.S. Department of Health and Human Services, 2012), available at: https://www.phe.gov/ Preparedness/mcm/phemce/Documents/ 2012-PHEMCE-Strategy.pdf, accessed October 16, 2012. 6. Srinivasan A., ‘‘Glanders in a Military Research Microbiologist,’’ The New England Journal of Medicine, vol. 345(4), pp. 256–258, 2001. 7. Gregory, B.C., and D.M. Waag, ‘‘Glanders,’’ in Textbook of Military Medicine: Medical Aspects of Chemical and Biological Warfare (Washington, DC: Office of the Surgeon General, 2007), available at: https://ke.army.mil/bordeninstitute/ published_volumes/biological_warfare/BWch06.pdf, accessed October 16, 2012. Dated: November 1, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–27146 Filed 11–6–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer Under the provisions of Section 3507(a)(1)(D) of the Paperwork SUMMARY: cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect geneenvironment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally-mediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 1,634 participants have reported being diagnosed with breast cancer. Frequency of Response: For the remainder of the study, women will be contacted once each year (when not scheduled for ‘‘triennial’’) to update contact information and health status (10 minutes per response); and asked to complete short (75 minutes per response) follow-up interviews or questionnaires (‘‘triennial’’) every three years. Follow-up and validation of reported incident breast cancer and other health outcomes is conducted under Clinical Exemption CE 2009–09– 004. Affected Public: Study participants, next-of-kin/proxies. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer; next-of-kin/proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 50,884 study participants or next-of-kin/ proxies. Estimated Number of Responses per Respondent: See annualized table below: Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 15 August 2012 on page 48993 and allowed 60-days for public comment. 1 public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision. Need and Use of Information Collection: This is to continue the Phase II follow-up of the Sister Study — a study of genetic and environmental risk factors for the development of breast cancer in a highrisk cohort of sisters of women who have had breast cancer. The etiology of breast cancer is complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non-genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a ESTIMATED ANNUALIZED BURDEN HOURS Estimated number of respondents Activity Estimated responses per respondent Average burden hours per response Estimated total burden hours requested pmangrum on DSK3VPTVN1PROD with NOTICES Annual Updates ............................................................................................... Follow-Up II (triennial) ...................................................................................... 33,923 16,961 1 1 10/60 1.25 5,654 21,202 Total .......................................................................................................... ........................ ........................ ........................ 26,856 Average Burden Hours Per Response: 42 minutes; and Estimated Total Annual Burden Hours Requested: 26,856. The estimated total annualized cost to respondents $537,120 (assuming VerDate Mar<15>2010 15:43 Nov 06, 2012 Jkt 229001 $20 hourly wage × 26,856). There are no capital, operating, or maintenance costs. Request For Comments: Written comments and/or suggestions from the public and affected agencies are invited PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66850-66851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27146]



[[Page 66850]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Public Workshop on Burkholderia: Exploring Current Issues and 
Identifying Regulatory Science Gaps

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following meeting: ``Public Workshop on Burkholderia: Exploring Current 
Issues and Identifying Regulatory Science Gaps.'' An interagency 
planning committee led by FDA, in collaboration with the Defense Threat 
Reduction Agency; the National Institute of Allergy and Infectious 
Diseases, a component of the National Institutes of Health; the Centers 
for Disease Control and Prevention; the U.S. Army Medical Research 
Institute of Infectious Diseases; the Biomedical Advanced Research and 
Development Authority; the Chemical Biological Medical Systems Joint 
Project Management Office; the U.S. Strategic Command Center for 
Combating Weapons of Mass Destruction; and the Joint Science and 
Technology Office for Chemical and Biological Defense, developed this 
workshop to present the most current information on melioidosis (caused 
by Burkholderia pseudomallei) and glanders (caused by B. mallei), with 
the general purpose of building on information presented at previous 
meetings and identifying future areas of research needed to advance 
animal model development and to advance candidate medical 
countermeasures (MCMs) for approval, licensure, or clearance.

DATES: This public workshop will be held on Thursday, November 29, 
2012, from 8 a.m. EST to 5 p.m. EST, and Friday, November 30, 2012, 
from 8 a.m. EST to 12 noon EST. Persons interested in attending the 
workshop in person or viewing via Webcast must register by Wednesday, 
November 21, 2012, at 5 p.m. EST.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993-0002. Information regarding 
special accommodations due to a disability, visitor parking, and 
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for 
You,'' click on ``Public Meetings at the FDA White Oak Campus.'' Please 
note that visitors to the White Oak Campus must enter through Building 
1.

FOR FURTHER INFORMATION CONTACT: Pamela Chamberlain, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 4122, 301-796-2968, FAX: 301-
847-8615, email: Pamela.Chamberlain@fda.hhs.gov, Web site: https://www.fda.gov/medicalcountermeasures.

SUPPLEMENTARY INFORMATION:

I. Background

    B. pseudomallei is a gram-negative bacterial pathogen that causes 
melioidosis, a disease endemic in Southeast Asia and northern 
Australia. Melioidosis is historically associated with a high mortality 
rate due to the speed with which septicemia develops and the inherent 
resistance of the bacteria to several classes of antibiotics. For 
example, a 20-year prospective study of melioidosis in northern 
Australia found an overall mortality of 14 percent and a 50 percent 
mortality rate for patients with septic shock (Ref. 1). A 9-year 
prospective study of melioidosis in northeast Thailand found an overall 
mortality rate of 42.6 percent (Ref. 2). Prolonged courses of 
antibiotics are required to treat melioidosis (Ref. 3). Despite 
prolonged antimicrobial therapy, recurrent disease is common (at a rate 
of greater than or equal to 6 percent in the first year) (Refs. 1 and 
4). In addition to the public health threat posed by naturally 
occurring infections, B. pseudomallei has been determined to pose a 
material threat sufficient to affect the United States' national 
security (Ref. 5).
    B. mallei (formerly Pseudomonas mallei) is a gram-negative, 
bacterial pathogen that causes glanders and is primarily a zoonotic 
disease in Africa, Asia, the Middle East, and Central/South America. 
Natural glanders infections occur primarily in horses, donkeys, and 
mules, but most mammals have some degree of susceptibility. While human 
susceptibility to B. mallei infection has not been studied indepth, the 
organism is highly infectious in the laboratory setting. Prolonged 
antimicrobial therapy is required to treat B. mallei infection and 
prevent its relapse (Refs. 6 and 7). B. mallei has also been determined 
to pose a material threat sufficient to affect the United States' 
national security (Ref. 5).
    Because of the lengthy antibiotic therapy required to treat 
melioidosis and glanders and the suboptimal clinical outcomes, lack of 
vaccines, possible biothreat applications, and public health 
implications, there is significant interest in developing new MCMs as 
well as improved animal models to evaluate candidate MCMs for these 
diseases. This public workshop was designed with specific goals that 
include, but are not limited to:
     Review of the current state of the knowledge of human 
melioidosis and glanders;
     Discussion of the availability of relevant animal models 
and their current state of development;
     Discussion of the availability, development, procurement, 
and stockpiling of relevant MCMs, including diagnostic tests; and
     Identification of the scientific and regulatory 
considerations associated with testing and development of MCMs for safe 
and effective treatment or prevention of these diseases.

II. How to Register

    If you wish to attend the public workshop or view via Webcast, you 
must register at https://www.fda.gov/medicalcountermeasures by 
Wednesday, November 21, 2012, at 5 p.m. EST. When registering, you must 
provide the following information: (1) Your name, (2) title, (3) 
company or organization (if applicable), (4) mailing address, (5) phone 
number, and (6) email address.
    There is no fee to register for the public meeting and registration 
will be on a first-come, first-served basis. Early registration is 
recommended because seating is limited.
    If you need special accommodations due to a disability, please 
enter pertinent information in the ``Notes'' section of the electronic 
registration form when you register.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at https://www.regulations.gov. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

    1. Currie B.J., L. Ward, and A.C. Cheng, ``The Epidemiology and 
Clinical Spectrum of Melioidosis: 540 Cases From the 20 Year Darwin 
Prospective Study,'' Public Library of Science Neglected Tropical 
Diseases, vol. 4(11):e900, 2010.

[[Page 66851]]

    2. Limmathurotsakul D., S. Wongratanacheewin, N. 
Teerawattanasook, et al, ``Increasing Incidence of Human Melioidosis 
in Northeast Thailand,'' American Journal of Tropical Medicine and 
Hygiene, vol. 82(6), pp. 1113-1117, 2010.
    3. Wiersinga W.J., B.J. Currie, and S.J. Peacock, 
``Melioidosis,'' The New England Journal of Medicine, vol. 367(11), 
pp. 1035-1044, 2012.
    4. Limmathurotsakul D., W. Chaowagul, W. Chierakul, et al., 
``Risk Factors for Recurrent Melioidosis in Northeast Thailand,'' 
Clinical Infectious Diseases, vol. 43(8), pp. 979-986, 2006.
    5. U.S. Department of Health and Human Services, ``2012 Public 
Health Emergency Medical Countermeasures Enterprise (PHEMCE) 
Strategy,'' (Washington, DC: U.S. Department of Health and Human 
Services, 2012), available at: https://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Strategy.pdf, accessed October 16, 
2012.
    6. Srinivasan A., ``Glanders in a Military Research 
Microbiologist,'' The New England Journal of Medicine, vol. 345(4), 
pp. 256-258, 2001.
    7. Gregory, B.C., and D.M. Waag, ``Glanders,'' in Textbook of 
Military Medicine: Medical Aspects of Chemical and Biological 
Warfare (Washington, DC: Office of the Surgeon General, 2007), 
available at: https://ke.army.mil/bordeninstitute/published_volumes/biological_warfare/BW-ch06.pdf, accessed October 16, 2012.

    Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27146 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P
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