Cooperative Agreement to Support the Foodborne Disease Burden Epidemiology Reference Group of the World Health Organization (U18), 55793-55795 [2010-22863]

Download as PDF 55793 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices The case plan is a written document that provides a narrative description of the child-specific program of care. Federal regulations at 45 CFR 1356.21(g) and section 475(1) of the Act delineate the specific information that should be addressed in the case plan. The Administration for Children and Families (ACF) does not specify a recordkeeping format for the case plan nor does ACF require submission of the document to the Federal government. Number of respondents Instrument Case Plan .................................................................................................. Estimated Total Annual Burden Hours: 2,891,169. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the 4.79 BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. Average number of responses per respondent In order to help carry out its mission, the Office for the Advancement of Telehealth (OAT) created a set of performance measures that grantees can use to evaluate the effectiveness of their services programs and monitor their progress through the use of performance reporting data. As required by the Government Performance and Review Act of 1993 (GPRA), all Federal agencies must develop strategic plans describing their overall goal and objectives. OAT has worked with its grantees to develop performance measures to be used to evaluate and monitor the progress of the grantees. Grantee goals are to: improve access to needed services; reduce rural practitioner isolation; improve health system productivity and efficiency; and improve patient outcomes. In each of these categories, specific indicators were designed to be reported through a performance monitoring Web site. The estimates of burden are as follows: Total responses 2 Hours per response 1,334 7 [FR Doc. 2010–22797 Filed 9–13–10; 8:45 am] 9,338 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2010–N–0466] BILLING CODE 4165–15–P Food and Drug Administration Cooperative Agreement to Support the Foodborne Disease Burden Epidemiology Reference Group of the World Health Organization (U18) ACTION: Jkt 220001 Total burden hours Dated: September 7, 2010. Sahira Rafiullah, Director, Division of Policy and Information Coordination. Food and Drug Administration, HHS. 16:38 Sep 13, 2010 2,891,169 HRSA Telehealth Outcome Measures (OMB No. 0915–0311)—Extension AGENCY: VerDate Mar<15>2010 Total burden hours The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: [FR Doc. 2010–22788 Filed 9–13–10; 8:45 am] 667 Average burden hours per response 1 Dated: September 7, 2010. Robert Sargis, Reports Clearance Officer. Performance Measurement Tool ......................................... jlentini on DSKJ8SOYB1PROD with NOTICES 603,453 Number of respondents Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Number of responses per respondent Administration for Children and Families. Form Case plan information is recorded in a format developed and maintained by the State or Tribal child welfare agency. Respondents: State and Tribe title IV– B and title IV–E agencies. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM Notice. 14SEN1 55794 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2010 (FY10) to the World Health Organization (WHO). One of the primary goals of the WHO is to provide for timely collaboration on multinational cooperative activities. DATES: Important dates are as follows: 1. The application due date is September 16, 2010. 2. The anticipated start date is September 2010. 3. The opening date is September 16, 2010. 4. The expiration date is September 30, 2010. FOR FURTHER INFORMATION CONTACT: Center Contact: Salvatore Evola, Center for Food Safety and Applied Nutrition (HFS–300), 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2164, e-mail: evola.salvatore@fda.hhs.gov. Grants Management Contact: Kimberly Pendleton, Division of Acquisition Support and Grants (HFA– 500), Food and Drug Administration, 5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301–827–9363, FAX: 301– 827–7101, e-mail: Kimberly.Pendleton@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at https:// www.fda.gov/Food/NewsEvents/ ucm176500.htm. SUMMARY: SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description Catalog of Federal Domestic Assistance Number: 93.103 A. Background jlentini on DSKJ8SOYB1PROD with NOTICES This funding opportunity is a single source application for the award of a cooperative agreement to the WHO to support the Initiative to Estimate the Global Burden of Foodborne Diseases— Foodborne Disease Burden Epidemiology Reference Group (FERG). This cooperative agreement ensures FDA’s participation and leadership in important international risk assessment and public health efforts involving microbiological and chemical hazards. Competition is limited to WHO because it is the parent organization of FERG. B. Research Objectives The WHO’s FERG comprises over 30 internationally renowned experts in a broad range of disciplines relevant to global foodborne disease epidemiology. FERG consists of the following groups: VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 • a Core (or Steering) Group to coordinate and oversee the scientific work; • four different Thematic Task Forces advancing the work in specific areas: Infectious diseases, chemicals and toxins, source attribution, and country burden of disease protocols; and • external resource advisers who are invited on an ad hoc basis to provide specific expertise. FERG is charged with the following tasks: • assemble, appraise, and report on the current, the projected, and the averted burden of foodborne disease estimates; • conduct epidemiological reviews for mortality, morbidity, and disability in each of the major foodborne diseases; • provide models for the estimation of foodborne disease burden where data are lacking; • develop cause attribution models to estimate the proportion of diseases that are foodborne; and, most importantly, • use the FERG models to develop user-friendly tools for burden of foodborne disease studies at country level. In addition, FERG aims to estimate the global human health burden (expressed in Disability-Adjusted Life Years (DALYs)) of foodborne disease. FERG will initially focus on microbial, parasitic, zoonotic, and chemical contamination of food with an emphasis on diseases whose incidence and severity is thought to be high, and on pathogens and chemicals that are most likely to contaminate food and which have a high degree of preventability. FERG is supported by the WHO Secretariat, comprising nine WHO Departments as well as international organizations (such as FAO, United Nations Environment Programme etc.) with an interest in foodborne disease burden estimation. This agreement will strengthen and allow WHO to continue its work in important international risk assessment and public health efforts. This agreement will also assist FDA in future assessments of the potential hazards, risks, and public health impact of foodborne disease. WHO is an umbrella organization that provides for timely international collaboration on multinational cooperative activities. The evaluations that are produced by WHO expert groups are based on sound science that contributes to improved public health and food safety worldwide. The following activities are to be supported by this cooperative agreement: (1) Schedule, plan, and conduct appropriate work groups, consultations, and committee meetings; PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 (2) identify advisers, and prepare written working papers summarizing the data on foodborne contaminants under consideration; and (3) prepare written working papers and technical documents for the FAO/WHO Expert Consultations related to contaminants (microbiological and chemical) in food. C. Eligibility Information Competition is limited to WHO because it has unique expertise and capacity found nowhere else. As part of the implementation of the WHO Global Strategy for Food Safety, WHO launched the Initiative to Estimate the Global Burden of Foodborne Diseases from all major causes (of microbiological, parasitic, and chemical origin) and in 2007 established FERG to estimate the global health burden of foodborne disease (and to express the estimate in DALYs) (https://www.who.int/ foodsafety/foodborne_disease/ferg). (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) FERG is a multisectoral and multidisciplinary group of global experts in foodborne diseases and representatives from numerous UN and other international agencies as well as National bodies (including the U.S. agencies FDA, United States Department of Agriculture and Centers for Disease Control and Prevention, among others). FERG operates through several Task Forces in the area of parasitic diseases, enteric diseases, chemicals and toxins, and source attribution (the latter aims to provide evidence that links burden of disease to specific food commodities, where possible). While FERG is reviewing all existing scientific evidence, including surveillance data, the full picture of the global health burden of foodborne disease can only be established if national level estimates of the health burden of foodborne disease are collected. FERG therefore launched the Country Studies Task Force which aims to strengthen the capacity of countries to undertake national burden of foodborne disease assessments, and provides countries with tools with which to conduct these studies and continue to monitor disease burden in the long-term. A further strength of such data lies in its ability to assist countries to detect important food safety threats early and to make and apply food safety policies and interventions based on sound scientific evidence pertinent to that country. WHO aims to conduct such studies in all six regions over the coming years. E:\FR\FM\14SEN1.SGM 14SEN1 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices II. Award Information/Funds Available A. Award Amount The estimated amount of support in FY10 will be up to $100,000 total costs (direct plus indirect costs), with the possibility of 2 additional years of support for a total (over 3 years) of up to $300,000, subject to the availability of funds. B. Length of Support The award will provide 1 year of support, with the possibility of 2 additional years of support, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations. jlentini on DSKJ8SOYB1PROD with NOTICES III. Paper Application, Registration, and Submission Information To submit a paper application in response to this FOA, applicants should first review the full announcement located at https://www.fda.gov. Persons interested in applying for a grant may obtain an application at https:// grants.nih.gov/grants/forms.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) For all paper application submissions, the following steps are required: • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With Central Contractor Registration • Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. Step 3, in detail, can be found at https:// commons.era.nih.gov/commons/ registration/registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Kimberly Pendleton, Division of Acquisition Support and Grants (HFA–500), Food and Drug Administration, 5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301–827–9363, FAX: 301–827–7101, email: Kimberly.Pendleton@fda.hhs.gov. Dated: September 9, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–22863 Filed 9–13–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https:// www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, Room 2–1042, One Choke Cherry Road, Rockville, Maryland 20857; 240–276– 2600 (voice), 240–276–2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 55795 certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227, 414–328– 7840/800–877–7016 (Formerly: Bayshore Clinical Laboratory). ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585–429–2264. Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118, 901–794–5770/888–290– 1150. Aegis Analytical Laboratories, 345 Hill Ave., Nashville, TN 37210, 615–255– 2400 (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc.). Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504–361–8989/ 800–433–3823 (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.). Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804–378–9130 (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.). Baptist Medical Center-Toxicology Laboratory, 11401 I–30, Little Rock, AR 72209–7056, 501–202–2783 (Formerly: Forensic Toxicology Laboratory Baptist Medical Center). Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215–2802, 800– 445–6917. Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602, 229–671– 2281, DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974, 215–674–9310. DynaLIFE Dx *, 10150–102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2, 780–451–3702/800–661–9876 (Formerly: Dynacare Kasper Medical Laboratories). ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609. E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55793-55795]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22863]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0466]


Cooperative Agreement to Support the Foodborne Disease Burden 
Epidemiology Reference Group of the World Health Organization (U18)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 55794]]

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intention to receive and consider a single source application for the 
award of a cooperative agreement in fiscal year 2010 (FY10) to the 
World Health Organization (WHO). One of the primary goals of the WHO is 
to provide for timely collaboration on multinational cooperative 
activities.

DATES: Important dates are as follows:
    1. The application due date is September 16, 2010.
    2. The anticipated start date is September 2010.
    3. The opening date is September 16, 2010.
    4. The expiration date is September 30, 2010.

FOR FURTHER INFORMATION CONTACT: Center Contact: Salvatore Evola, 
Center for Food Safety and Applied Nutrition (HFS-300), 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2164, e-mail: 
evola.salvatore@fda.hhs.gov.
    Grants Management Contact: Kimberly Pendleton, Division of 
Acquisition Support and Grants (HFA-500), Food and Drug Administration, 
5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301-827-9363, FAX: 
301-827-7101, e-mail: Kimberly.Pendleton@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://www.fda.gov/Food/NewsEvents/ucm176500.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    This funding opportunity is a single source application for the 
award of a cooperative agreement to the WHO to support the Initiative 
to Estimate the Global Burden of Foodborne Diseases--Foodborne Disease 
Burden Epidemiology Reference Group (FERG). This cooperative agreement 
ensures FDA's participation and leadership in important international 
risk assessment and public health efforts involving microbiological and 
chemical hazards. Competition is limited to WHO because it is the 
parent organization of FERG.

B. Research Objectives

    The WHO's FERG comprises over 30 internationally renowned experts 
in a broad range of disciplines relevant to global foodborne disease 
epidemiology.
    FERG consists of the following groups:
     a Core (or Steering) Group to coordinate and oversee the 
scientific work;
     four different Thematic Task Forces advancing the work in 
specific areas: Infectious diseases, chemicals and toxins, source 
attribution, and country burden of disease protocols; and
     external resource advisers who are invited on an ad hoc 
basis to provide specific expertise.
    FERG is charged with the following tasks:
     assemble, appraise, and report on the current, the 
projected, and the averted burden of foodborne disease estimates;
     conduct epidemiological reviews for mortality, morbidity, 
and disability in each of the major foodborne diseases;
     provide models for the estimation of foodborne disease 
burden where data are lacking;
     develop cause attribution models to estimate the 
proportion of diseases that are foodborne; and, most importantly,
     use the FERG models to develop user-friendly tools for 
burden of foodborne disease studies at country level.
    In addition, FERG aims to estimate the global human health burden 
(expressed in Disability-Adjusted Life Years (DALYs)) of foodborne 
disease. FERG will initially focus on microbial, parasitic, zoonotic, 
and chemical contamination of food with an emphasis on diseases whose 
incidence and severity is thought to be high, and on pathogens and 
chemicals that are most likely to contaminate food and which have a 
high degree of preventability.
    FERG is supported by the WHO Secretariat, comprising nine WHO 
Departments as well as international organizations (such as FAO, United 
Nations Environment Programme etc.) with an interest in foodborne 
disease burden estimation.
    This agreement will strengthen and allow WHO to continue its work 
in important international risk assessment and public health efforts. 
This agreement will also assist FDA in future assessments of the 
potential hazards, risks, and public health impact of foodborne 
disease. WHO is an umbrella organization that provides for timely 
international collaboration on multinational cooperative activities. 
The evaluations that are produced by WHO expert groups are based on 
sound science that contributes to improved public health and food 
safety worldwide. The following activities are to be supported by this 
cooperative agreement: (1) Schedule, plan, and conduct appropriate work 
groups, consultations, and committee meetings; (2) identify advisers, 
and prepare written working papers summarizing the data on foodborne 
contaminants under consideration; and (3) prepare written working 
papers and technical documents for the FAO/WHO Expert Consultations 
related to contaminants (microbiological and chemical) in food.

C. Eligibility Information

    Competition is limited to WHO because it has unique expertise and 
capacity found nowhere else. As part of the implementation of the WHO 
Global Strategy for Food Safety, WHO launched the Initiative to 
Estimate the Global Burden of Foodborne Diseases from all major causes 
(of microbiological, parasitic, and chemical origin) and in 2007 
established FERG to estimate the global health burden of foodborne 
disease (and to express the estimate in DALYs) (https://www.who.int/foodsafety/foodborne_disease/ferg). (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to the 
Web site after this document publishes in the Federal Register.) FERG 
is a multisectoral and multidisciplinary group of global experts in 
foodborne diseases and representatives from numerous UN and other 
international agencies as well as National bodies (including the U.S. 
agencies FDA, United States Department of Agriculture and Centers for 
Disease Control and Prevention, among others). FERG operates through 
several Task Forces in the area of parasitic diseases, enteric 
diseases, chemicals and toxins, and source attribution (the latter aims 
to provide evidence that links burden of disease to specific food 
commodities, where possible). While FERG is reviewing all existing 
scientific evidence, including surveillance data, the full picture of 
the global health burden of foodborne disease can only be established 
if national level estimates of the health burden of foodborne disease 
are collected. FERG therefore launched the Country Studies Task Force 
which aims to strengthen the capacity of countries to undertake 
national burden of foodborne disease assessments, and provides 
countries with tools with which to conduct these studies and continue 
to monitor disease burden in the long-term. A further strength of such 
data lies in its ability to assist countries to detect important food 
safety threats early and to make and apply food safety policies and 
interventions based on sound scientific evidence pertinent to that 
country. WHO aims to conduct such studies in all six regions over the 
coming years.

[[Page 55795]]

II. Award Information/Funds Available

A. Award Amount

    The estimated amount of support in FY10 will be up to $100,000 
total costs (direct plus indirect costs), with the possibility of 2 
additional years of support for a total (over 3 years) of up to 
$300,000, subject to the availability of funds.

B. Length of Support

    The award will provide 1 year of support, with the possibility of 2 
additional years of support, contingent upon satisfactory performance 
in the achievement of project and program reporting objectives during 
the preceding year and the availability of Federal fiscal year 
appropriations.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement located at https://www.fda.gov. Persons interested in applying for a grant may obtain an 
application at https://grants.nih.gov/grants/forms.htm. (FDA has 
verified the Web site address, but FDA is not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.) For all paper application submissions, the following 
steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration
     Step 3: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to: Kimberly Pendleton, Division of 
Acquisition Support and Grants (HFA-500), Food and Drug Administration, 
5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301-827-9363, FAX: 
301-827-7101, e-mail: Kimberly.Pendleton@fda.hhs.gov.

    Dated: September 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22863 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S
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