National Center for Natural Products Research, University of Mississippi; Single Source Cooperative Agreement; Catalog of Federal Domestic Assistance Number 93.103; Request for Application, 50434-50435 [E6-14109]

Download as PDF 50434 Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Notices TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 510.305 1There 1,070 Dated: August 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14076 Filed 8–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Center for Natural Products Research, University of Mississippi; Single Source Cooperative Agreement; Catalog of Federal Domestic Assistance Number 93.103; Request for Application AGENCY: Food and Drug Administration, HHS. Notice. I. Funding Opportunity Description cprice-sewell on PROD1PC66 with NOTICES Total Annual Records 1 Hours per Record 1,070 Total Hours 0.03 32.10 are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting burden on industry is 36.6 hours, as shown in table 1 of this document. Industry estimates it takes about 0.25 hours to submit the application. We estimate 132 original and supplemental applications and voluntary revocations for a total of 33 hours (132 submissions x 0.25 hours). An additional 3.6 hours are added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 36 hours for maintaining and retrieving labels as required by 21 CFR 510.305. We estimated .03 hours for each of approximately 1,070 licensees. Thus, the total burden for recordkeeping requirements is 32.10 hours (1,070 licensees x 0.03 hours). ACTION: Annual Frequency per Recordkeeping The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source competing continuation application for the award of a cooperative agreement in fiscal year (FY 2006) to the University of Mississippi (UM) to support the National Center for Natural Products Research (NCNPR), which is located on UM’s Campus at Oxford, MS, for up to $2.3 million for FY06 (direct plus indirect costs combined), the total amount being subject to annual budget appropriations. The funds will provide additional support to the UM’s NCNPR for the purpose of promoting more VerDate Aug<31>2005 14:57 Aug 24, 2006 Jkt 208001 efficient development and dissemination of natural products research and science and will complement the diverse activities of both the public and private sectors that may become collaborators. Subject to the availability of Federal funds and successful performance, 4 additional years of support will be available. FDA will support the research covered by this notice under the authority of section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241). FDA’s research program is described in the Catalog of Federal Domestic Assistance No.93.103. Before entering into cooperative agreements, FDA carefully considers the benefits such agreements will provide to the public. II. Eligibility Information FDA believes that there is compelling evidence that UM is uniquely qualified to fulfill the objectives of the proposed cooperative agreement. UM is a comprehensive research institution with numerous academic programs relevant to FDA’s mission and the resources to support the Center for Food Safety and Nutrition’s (CFSAN’s) areas of interest. NCNPR, which opened in July 1995, is a division of the Research Institute of Pharmaceutical Sciences of UM’s School of Pharmacy. NCNPR was created to bring together an alliance of academia, government, and industry to integrate research, development, and commercialization of potentially useful natural products. The goal of NCNPR in botanical dietary supplements is to enable safe, effective, and proper use of high quality botanical products by informed professionals and consumers. NCNPR conducts basic and applied multidisciplinary research to discover and develop natural products for use as dietary supplements. NCNPR also maintains a repository of several thousand natural product extracts that are available for screening by collaborators working in other areas. NCNPR has substantial expertise to carry forward specific discoveries, products, and technologies. Most of the projects to develop promising high priority products or technology are conducted in collaboration with industrial partners or through externally PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 funded grants and contract. NCNPR is staffed with a highly synergistic mix of full-time research faculty and support staff and employs a number of undergraduate and graduate students and postdoctoral scientists. Together, the faculty, scientists, staff, students, and external collaborators, provide the human resources required to accomplish the research and development goals of NCNPR. Collaboration between the public and private sector is an efficient means for both FDA and the University to remain current with scientific and technical accomplishments from a natural products research perspective. Harmonizing research activities is but one example of the need for and use of this natural products research knowledge and expertise. The partnership between FDA and UM will provide both the technical and educational expertise necessary for effective mechanisms that will facilitate the movement of new technology and provide direct usefulness to FDA’s scientific and enforcement initiatives. As of October 1, 2003, applicants are required to have a Dun and Bradstreet Number (DUNS) to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, applicants should go to https:// www.grants.gov/RequestaDUNS or call 1–866–705–5711. (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.) III. Application and Submission To comply with the President’s Management Agenda, HHS is participating as a partner in the new government-wide Grants.gov Web site. Users of Grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the Grants.gov Web site. We encourage applicant submission through Grants.gov. If submitted other than electronically, please contact Gladys M. Bohler for guidance (see contact E:\FR\FM\25AUN1.SGM 25AUN1 Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Notices information in the paragraph that follows). DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Announcement Type: New competitive Funding Announcement Number: HHS–2006–IHS–NU–0001 Catalog of Federal Domestic Assistance Number(s): 93.933 Key Dates: Application deadline Date: September 15, 2006. Review Date: September 20–22, 2006. Award Announcement Date: September 25, 2006. Earliest Anticipated Start Date: September 29, 2006. IV. Submission Dates and Times cprice-sewell on PROD1PC66 with NOTICES For further information contact Gladys M. Bohler, Grants Management Specialist, Division of Contracts and Grants Management (HFA–500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301–827– 7168, e-mail: Gladys.Melendez_Bohler@fda.hhs.gov. A copy of the complete Request for Applications (RFA) can also be viewed on FDA’s Center for Food Safety and Applied Nutrition Web site at https:// www.foodsafety.gov/nfsg/ fsggrant.html(FDA has verified the Web site and its address but we are not responsible for changes to the Web site or its address after this document publishes in the Federal Register.) 1. Funding Opportunity Description The application receipt date is September 25, 2006. The application will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until the established receipt date. The application will be considered received on time if hand delivered to the address noted previously (see section III of this document) before the established receipt date, or sent or mailed by the receipt date as shown by a legible U.S. Postal Service dated postmark or a legible dated receipt from a commercial carrier. Private metered postmarks shall not be acceptable as proof of timely mailing. If not received on time the application will not be considered for review and will be returned to the applicant. (Applicants should note the U.S. Postal Service does not uniformly provide dated postmarks. Before relying on this method, applicants should check with their local post office). Please do not send applications to the Center for Scientific Research (CSR) at the National Institutes of Health (NIH). Any application sent to NIH/CSR that is forwarded to the FDA Grants Management Office and not received in time for orderly processing will be judged non-responsive and returned to the applicant. Currently, FDA is unable to receive applications electronically. The applicant is advised that FDA does not adhere to the page limitations or the type size and line spacing requirements imposed by NIH for its applications. The Indian Health Service (IHS), Office of Clinical and Preventive Services, Division of Nursing Services announces competitive grant applications for Public Health Nurse (PHN) Disease Prevention and Health Promotion (DPHP). This program is authorized by the Snyder Act, 25 U.S.C. 13; Section 301(a), Public Health Service Act, as amended; and Indian Health Care Improvement Act, 25 U.S.C. 1652. This program is described at 93.933 in the Catalog of Federal Domestic Assistance. The Public Health Nursing (PHN) Service is the prevention of illness, promotion and maintenance of health through the provision of therapeutic services, counseling, education and advocacy services. This is accomplished through assessment and identification of the individual, family and community needs, promotion of consumer participation in establishing health goals, planning programs to meet identified needs and coordination of community health programs and services. The public-health nursing program is flexible and individualized to meet needs within existing resources and takes into account prevailing economic, cultural, social, and geographic characteristics. Tribal PHN Programs may submit applications for review. The highest scored applications will be funded for two years based on availability of funds and satisfactory progress. The content of the application should relate directly to the basic emphasis of the PHN program’s scope of services as indicated by American Nursing Association PHN Standards of Care, Government Performance Results Act (GPRA) Dated: August 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14109 Filed 8–24–06; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 14:57 Aug 24, 2006 Jkt 208001 Office of Clinical and Preventive Services; Division of Nursing Services, Public Health Nursing PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 50435 measures associated with PHN practice such as: Alcohol Screening (Fetal Alcohol Syndrome (FAS) Prevention); Domestic (Intimate Partner) Violence Screening; Breast feeding; Childhood Immunization; Adult Immunization; CVD Prevention (Cholesterol Screening); Obesity Assessment; Tobacco Use Assessment; Prenatal Human Immunodeficiency Virus (HIV) Screening; and sound program planning and evaluation principles. Proposal must include measurable health outcomes. Outline goals and anticipated results linked to outcome objectives, process objectives, and proposed activities performed in the home or community setting as demonstrated through quality data improvement of these activities. II. Award Information Type of Awards: Grant Estimated Funds Available: The total amount identified for project period is $2,352,000. The total for each 12 month period is $1,176,000. The awards are for 24 months in duration and the average award is approximately $100,000. Awards under this announcement are subject to availability of funds and satisfactory performance. Anticipated Number of Awards: 11 awards will be made under the Program. Project Period: 24 months. Award Amount: $100,000 per year. III. Eligibility Information 1. Eligible Applicants must be one of the following (please specify in the application which category applies to each applicant): A. Federally-recognized Indian Tribe, B. Non-Profit Urban Indian Organization as defined by Urbans-25 U.S.C. 1603(f), or C. Non-Profit Tribal organizations as defined by Indian Health Care Improvement Act (IHCIA), 25 U.S.C. 1603(e). 2. Supporting Documentation to Determine Eligibility: A. Tribal Resolution—If the applicant is an Indian Tribe or Tribal organization, a resolution from the Tribal government of all Tribes to be served supporting the project must accompany the application submission. Applications by Tribal organizations will be require resolutions if the current Tribal resolutions under which they operate would encompass the proposed activities. In this instance a copy of the current resolution must accompany the application. The list of Tribes to be served by the project in the proposal must match the set of appended resolutions. If a resolution from an appropriate representative of each Tribe E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Notices]
[Pages 50434-50435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14109]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


National Center for Natural Products Research, University of 
Mississippi; Single Source Cooperative Agreement; Catalog of Federal 
Domestic Assistance Number 93.103; Request for Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

I. Funding Opportunity Description

    The Food and Drug Administration (FDA) is announcing its intention 
to receive and consider a single source competing continuation 
application for the award of a cooperative agreement in fiscal year (FY 
2006) to the University of Mississippi (UM) to support the National 
Center for Natural Products Research (NCNPR), which is located on UM's 
Campus at Oxford, MS, for up to $2.3 million for FY06 (direct plus 
indirect costs combined), the total amount being subject to annual 
budget appropriations. The funds will provide additional support to the 
UM's NCNPR for the purpose of promoting more efficient development and 
dissemination of natural products research and science and will 
complement the diverse activities of both the public and private 
sectors that may become collaborators.
    Subject to the availability of Federal funds and successful 
performance, 4 additional years of support will be available. FDA will 
support the research covered by this notice under the authority of 
section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241). 
FDA's research program is described in the Catalog of Federal Domestic 
Assistance No.93.103. Before entering into cooperative agreements, FDA 
carefully considers the benefits such agreements will provide to the 
public.

II. Eligibility Information

    FDA believes that there is compelling evidence that UM is uniquely 
qualified to fulfill the objectives of the proposed cooperative 
agreement. UM is a comprehensive research institution with numerous 
academic programs relevant to FDA's mission and the resources to 
support the Center for Food Safety and Nutrition's (CFSAN's) areas of 
interest.
    NCNPR, which opened in July 1995, is a division of the Research 
Institute of Pharmaceutical Sciences of UM's School of Pharmacy. NCNPR 
was created to bring together an alliance of academia, government, and 
industry to integrate research, development, and commercialization of 
potentially useful natural products.
    The goal of NCNPR in botanical dietary supplements is to enable 
safe, effective, and proper use of high quality botanical products by 
informed professionals and consumers. NCNPR conducts basic and applied 
multidisciplinary research to discover and develop natural products for 
use as dietary supplements. NCNPR also maintains a repository of 
several thousand natural product extracts that are available for 
screening by collaborators working in other areas.
    NCNPR has substantial expertise to carry forward specific 
discoveries, products, and technologies. Most of the projects to 
develop promising high priority products or technology are conducted in 
collaboration with industrial partners or through externally funded 
grants and contract. NCNPR is staffed with a highly synergistic mix of 
full-time research faculty and support staff and employs a number of 
undergraduate and graduate students and postdoctoral scientists. 
Together, the faculty, scientists, staff, students, and external 
collaborators, provide the human resources required to accomplish the 
research and development goals of NCNPR.
    Collaboration between the public and private sector is an efficient 
means for both FDA and the University to remain current with scientific 
and technical accomplishments from a natural products research 
perspective. Harmonizing research activities is but one example of the 
need for and use of this natural products research knowledge and 
expertise. The partnership between FDA and UM will provide both the 
technical and educational expertise necessary for effective mechanisms 
that will facilitate the movement of new technology and provide direct 
usefulness to FDA's scientific and enforcement initiatives.
    As of October 1, 2003, applicants are required to have a Dun and 
Bradstreet Number (DUNS) to apply for a grant or cooperative agreement 
from the Federal Government. The DUNS number is a 9-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, applicants should go to https://www.grants.gov/RequestaDUNS 
or call 1-866-705-5711. (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.)

III. Application and Submission

    To comply with the President's Management Agenda, HHS is 
participating as a partner in the new government-wide Grants.gov Web 
site. Users of Grants.gov will be able to download a copy of the 
application package, complete it offline, and then upload and submit 
the application via the Grants.gov Web site. We encourage applicant 
submission through Grants.gov. If submitted other than electronically, 
please contact Gladys M. Bohler for guidance (see contact

[[Page 50435]]

information in the paragraph that follows).
    For further information contact Gladys M. Bohler, Grants Management 
Specialist, Division of Contracts and Grants Management (HFA-500), Food 
and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-
827-7168, e-mail: Gladys.Melendez--Bohler@fda.hhs.gov. A copy of the 
complete Request for Applications (RFA) can also be viewed on FDA's 
Center for Food Safety and Applied Nutrition Web site at https://
www.foodsafety.gov/nfsg/fsggrant.html(FDA has verified the Web site and 
its address but we are not responsible for changes to the Web site or 
its address after this document publishes in the Federal Register.)

IV. Submission Dates and Times

    The application receipt date is September 25, 2006. The application 
will be accepted from 8 a.m. to 4:30 p.m., Monday through Friday until 
the established receipt date. The application will be considered 
received on time if hand delivered to the address noted previously (see 
section III of this document) before the established receipt date, or 
sent or mailed by the receipt date as shown by a legible U.S. Postal 
Service dated postmark or a legible dated receipt from a commercial 
carrier. Private metered postmarks shall not be acceptable as proof of 
timely mailing. If not received on time the application will not be 
considered for review and will be returned to the applicant. 
(Applicants should note the U.S. Postal Service does not uniformly 
provide dated postmarks. Before relying on this method, applicants 
should check with their local post office). Please do not send 
applications to the Center for Scientific Research (CSR) at the 
National Institutes of Health (NIH). Any application sent to NIH/CSR 
that is forwarded to the FDA Grants Management Office and not received 
in time for orderly processing will be judged non-responsive and 
returned to the applicant. Currently, FDA is unable to receive 
applications electronically. The applicant is advised that FDA does not 
adhere to the page limitations or the type size and line spacing 
requirements imposed by NIH for its applications.

    Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14109 Filed 8-24-06; 8:45 am]
BILLING CODE 4160-01-S
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