You are on page 1of 2

50434 Federal Register / Vol. 71, No.

165 / Friday, August 25, 2006 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Recordkeepers per Recordkeeping Records Record

510.305 1,070 1 1,070 0.03 32.10


1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated annual reporting efficient development and funded grants and contract. NCNPR is
burden on industry is 36.6 hours, as dissemination of natural products staffed with a highly synergistic mix of
shown in table 1 of this document. research and science and will full-time research faculty and support
Industry estimates it takes about 0.25 complement the diverse activities of staff and employs a number of
hours to submit the application. We both the public and private sectors that undergraduate and graduate students
estimate 132 original and supplemental may become collaborators. and postdoctoral scientists. Together,
applications and voluntary revocations Subject to the availability of Federal the faculty, scientists, staff, students,
for a total of 33 hours (132 submissions funds and successful performance, 4 and external collaborators, provide the
x 0.25 hours). An additional 3.6 hours additional years of support will be human resources required to
are added for the rare notice of available. FDA will support the research accomplish the research and
opportunity for a hearing to not approve covered by this notice under the development goals of NCNPR.
or revoke an application. Finally, we authority of section 301 of the Public Collaboration between the public and
estimate 36 hours for maintaining and Health Service (PHS) Act (42 U.S.C. private sector is an efficient means for
retrieving labels as required by 21 CFR 241). FDA’s research program is both FDA and the University to remain
510.305. We estimated .03 hours for described in the Catalog of Federal current with scientific and technical
each of approximately 1,070 licensees. Domestic Assistance No.93.103. Before accomplishments from a natural
Thus, the total burden for recordkeeping entering into cooperative agreements, products research perspective.
requirements is 32.10 hours (1,070 FDA carefully considers the benefits Harmonizing research activities is but
licensees x 0.03 hours). such agreements will provide to the one example of the need for and use of
Dated: August 18, 2006.
public. this natural products research
Jeffrey Shuren, II. Eligibility Information knowledge and expertise. The
Assistant Commissioner for Policy. partnership between FDA and UM will
FDA believes that there is compelling
[FR Doc. E6–14076 Filed 8–24–06; 8:45 am]
provide both the technical and
evidence that UM is uniquely qualified
educational expertise necessary for
BILLING CODE 4160–01–S to fulfill the objectives of the proposed
effective mechanisms that will facilitate
cooperative agreement. UM is a
the movement of new technology and
comprehensive research institution with
DEPARTMENT OF HEALTH AND provide direct usefulness to FDA’s
numerous academic programs relevant
HUMAN SERVICES scientific and enforcement initiatives.
to FDA’s mission and the resources to
support the Center for Food Safety and As of October 1, 2003, applicants are
Food and Drug Administration Nutrition’s (CFSAN’s) areas of interest. required to have a Dun and Bradstreet
NCNPR, which opened in July 1995, Number (DUNS) to apply for a grant or
National Center for Natural Products cooperative agreement from the Federal
is a division of the Research Institute of
Research, University of Mississippi; Government. The DUNS number is a 9-
Pharmaceutical Sciences of UM’s
Single Source Cooperative Agreement; digit identification number, which
School of Pharmacy. NCNPR was
Catalog of Federal Domestic uniquely identifies business entities.
created to bring together an alliance of
Assistance Number 93.103; Request Obtaining a DUNS number is easy and
academia, government, and industry to
for Application there is no charge. To obtain a DUNS
integrate research, development, and
AGENCY: Food and Drug Administration, commercialization of potentially useful number, applicants should go to http://
HHS. natural products. www.grants.gov/RequestaDUNS or call
The goal of NCNPR in botanical 1–866–705–5711. (FDA has verified the
ACTION: Notice. Web site address, but FDA is not
dietary supplements is to enable safe,
effective, and proper use of high quality responsible for any subsequent changes
I. Funding Opportunity Description to the Web site after this document
botanical products by informed
The Food and Drug Administration professionals and consumers. NCNPR publishes in the Federal Register.)
(FDA) is announcing its intention to conducts basic and applied III. Application and Submission
receive and consider a single source multidisciplinary research to discover
competing continuation application for and develop natural products for use as To comply with the President’s
the award of a cooperative agreement in dietary supplements. NCNPR also Management Agenda, HHS is
fiscal year (FY 2006) to the University maintains a repository of several participating as a partner in the new
of Mississippi (UM) to support the thousand natural product extracts that government-wide Grants.gov Web site.
National Center for Natural Products are available for screening by Users of Grants.gov will be able to
Research (NCNPR), which is located on collaborators working in other areas. download a copy of the application
UM’s Campus at Oxford, MS, for up to NCNPR has substantial expertise to package, complete it offline, and then
cprice-sewell on PROD1PC66 with NOTICES

$2.3 million for FY06 (direct plus carry forward specific discoveries, upload and submit the application via
indirect costs combined), the total products, and technologies. Most of the the Grants.gov Web site. We encourage
amount being subject to annual budget projects to develop promising high applicant submission through
appropriations. The funds will provide priority products or technology are Grants.gov. If submitted other than
additional support to the UM’s NCNPR conducted in collaboration with electronically, please contact Gladys M.
for the purpose of promoting more industrial partners or through externally Bohler for guidance (see contact

VerDate Aug<31>2005 14:57 Aug 24, 2006 Jkt 208001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1
Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Notices 50435

information in the paragraph that DEPARTMENT OF HEALTH AND measures associated with PHN practice
follows). HUMAN SERVICES such as: Alcohol Screening (Fetal
Alcohol Syndrome (FAS) Prevention);
Indian Health Service Domestic (Intimate Partner) Violence
For further information contact Screening; Breast feeding; Childhood
Gladys M. Bohler, Grants Management Office of Clinical and Preventive Immunization; Adult Immunization;
Specialist, Division of Contracts and Services; Division of Nursing Services, CVD Prevention (Cholesterol Screening);
Grants Management (HFA–500), Food Public Health Nursing Obesity Assessment; Tobacco Use
and Drug Administration, 5630 Fishers Assessment; Prenatal Human
Announcement Type: New
Lane, Rockville, MD 20857, 301–827– Immunodeficiency Virus (HIV)
competitive
7168, e-mail: Screening; and sound program planning
Funding Announcement Number:
Gladys.Melendez_Bohler@fda.hhs.gov. HHS–2006–IHS–NU–0001 and evaluation principles. Proposal
A copy of the complete Request for Catalog of Federal Domestic must include measurable health
Applications (RFA) can also be viewed Assistance Number(s): 93.933 outcomes. Outline goals and anticipated
on FDA’s Center for Food Safety and Key Dates: Application deadline Date: results linked to outcome objectives,
Applied Nutrition Web site at http:// September 15, 2006. process objectives, and proposed
www.foodsafety.gov/nfsg/ Review Date: September 20–22, activities performed in the home or
fsggrant.html(FDA has verified the Web 2006. community setting as demonstrated
site and its address but we are not Award Announcement Date: through quality data improvement of
responsible for changes to the Web site September 25, 2006. these activities.
or its address after this document Earliest Anticipated Start Date: II. Award Information
publishes in the Federal Register.) September 29, 2006.
Type of Awards: Grant
IV. Submission Dates and Times 1. Funding Opportunity Description Estimated Funds Available: The total
The Indian Health Service (IHS), amount identified for project period is
The application receipt date is $2,352,000. The total for each 12 month
September 25, 2006. The application Office of Clinical and Preventive
Services, Division of Nursing Services period is $1,176,000. The awards are for
will be accepted from 8 a.m. to 4:30 24 months in duration and the average
p.m., Monday through Friday until the announces competitive grant
applications for Public Health Nurse award is approximately $100,000.
established receipt date. The application Awards under this announcement are
will be considered received on time if (PHN) Disease Prevention and Health
Promotion (DPHP). This program is subject to availability of funds and
hand delivered to the address noted satisfactory performance.
previously (see section III of this authorized by the Snyder Act, 25 U.S.C.
Anticipated Number of Awards: 11
document) before the established receipt 13; Section 301(a), Public Health
awards will be made under the Program.
date, or sent or mailed by the receipt Service Act, as amended; and Indian
Project Period: 24 months.
Health Care Improvement Act, 25 U.S.C. Award Amount: $100,000 per year.
date as shown by a legible U.S. Postal
1652. This program is described at
Service dated postmark or a legible III. Eligibility Information
93.933 in the Catalog of Federal
dated receipt from a commercial carrier.
Domestic Assistance. 1. Eligible Applicants must be one of
Private metered postmarks shall not be
The Public Health Nursing (PHN) the following (please specify in the
acceptable as proof of timely mailing. If
Service is the prevention of illness, application which category applies to
not received on time the application promotion and maintenance of health
will not be considered for review and each applicant):
through the provision of therapeutic A. Federally-recognized Indian Tribe,
will be returned to the applicant. services, counseling, education and B. Non-Profit Urban Indian
(Applicants should note the U.S. Postal advocacy services. This is accomplished Organization as defined by Urbans-25
Service does not uniformly provide through assessment and identification of U.S.C. 1603(f), or
dated postmarks. Before relying on this the individual, family and community C. Non-Profit Tribal organizations as
method, applicants should check with needs, promotion of consumer defined by Indian Health Care
their local post office). Please do not participation in establishing health Improvement Act (IHCIA), 25 U.S.C.
send applications to the Center for goals, planning programs to meet 1603(e).
Scientific Research (CSR) at the identified needs and coordination of 2. Supporting Documentation to
National Institutes of Health (NIH). Any community health programs and Determine Eligibility:
application sent to NIH/CSR that is services. The public-health nursing A. Tribal Resolution—If the applicant
forwarded to the FDA Grants program is flexible and individualized is an Indian Tribe or Tribal
Management Office and not received in to meet needs within existing resources organization, a resolution from the
time for orderly processing will be and takes into account prevailing Tribal government of all Tribes to be
judged non-responsive and returned to economic, cultural, social, and served supporting the project must
the applicant. Currently, FDA is unable geographic characteristics. accompany the application submission.
to receive applications electronically. Tribal PHN Programs may submit Applications by Tribal organizations
The applicant is advised that FDA does applications for review. The highest will be require resolutions if the current
not adhere to the page limitations or the scored applications will be funded for Tribal resolutions under which they
type size and line spacing requirements two years based on availability of funds operate would encompass the proposed
imposed by NIH for its applications. and satisfactory progress. The content of activities. In this instance a copy of the
cprice-sewell on PROD1PC66 with NOTICES

Dated: August 18, 2006. the application should relate directly to current resolution must accompany the
the basic emphasis of the PHN application. The list of Tribes to be
Jeffrey Shuren,
program’s scope of services as indicated served by the project in the proposal
Assistant Commissioner for Policy. by American Nursing Association PHN must match the set of appended
[FR Doc. E6–14109 Filed 8–24–06; 8:45 am] Standards of Care, Government resolutions. If a resolution from an
BILLING CODE 4160–01–S Performance Results Act (GPRA) appropriate representative of each Tribe

VerDate Aug<31>2005 14:57 Aug 24, 2006 Jkt 208001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1