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Federal Register / Vol. 73, No.

8 / Friday, January 11, 2008 / Notices 2055

referral or services for individuals or Dated: January 2, 2008. encourage public participation
couples where violence is occurring. Quanah Crossland Stamps, consistent with regulations issued under
Applicants should be able to Commissioner, Administration for Native the National Environmental Policy Act
demonstrate knowledge of the Americans. (40 CFR 1501.4(b)), the agency is
information and services provided by [FR Doc. 08–56 Filed 1–10–08 8:45 am] placing the environmental assessment
domestic violence coalitions within the BILLING CODE 4184–01–M submitted with the petition that is the
community. subject of this notice on public display
vii. Funding Thresholds. The funding at the Division of Dockets Management
thresholds for this program will be DEPARTMENT OF HEALTH AND (see ADDRESSES) for public review and
revised to reflect ANA’s availability of HUMAN SERVICES comment.
funds within this special initiative Interested persons may submit to the
program area. These thresholds allow Food and Drug Administration Division of Dockets Management (see
ANA to provide funding to the [Docket No. 2007F–0478] ADDRESSES) written or electronic
maximum number of applicants. (Legal comments regarding this document.
authority: Section 803(a) and (d) and Kemira Oyi; Filing of Food Additive Submit a single copy of electronic
803C of the Native American Programs Petition (Animal Use); Partially comments or two paper copies of any
Act of 1974, as amended, 42 U.S.C. 2991 Ammoniated Formic Acid mailed comments, except that
band 2991b–3.) individuals may submit one paper copy.
viii. Project Periods. The project AGENCY: Food and Drug Administration, Comments are to be identified with the
periods reflect the review and HHS. docket number found in brackets in the
assessment of projects monitored under ACTION: Notice. heading of this document. Received
this special initiative program area. comments may be seen in the Division
These project periods allow ANA to SUMMARY: The Food and Drug
of Dockets Management between 9 a.m.
provide funding to the maximum Administration (FDA) is announcing and 4 p.m., Monday through Friday.
number of applicants. (Legal authority: that Kemira Oyi has filed a petition FDA will also place on public display
Section 803(a) and (d) and 803C of the proposing that the food additive any amendments to, or comments on,
Native American Programs Act of 1974, regulations be amended to provide for the petitioner’s environmental
as amended, 42 U.S.C. 2991b and the safe use of partially ammoniated assessment without further
2991b–3.) formic acid as a pH control agent in announcement in the Federal Register.
In the FY 08 PA, project periods will swine feed. If, based on its review, the agency finds
be: DATES: Submit written or electronic that an environmental impact statement
• Priority Area 1—Planning: 12 comments on the petitioner’s is not required and this petition results
months. environmental assessment by March 11, in a regulation, the notice of availability
• Priority Area 2—Implementation: 2008. of the agency’s finding of no significant
36 months. ADDRESSES: You may submit written impact and the evidence supporting that
(C) ANA SEDS: In the FY 2008 PA for comments to the Division of Dockets finding will be published with the
both priority areas, the program areas of Management (HFA–305), Food and Drug regulation in the Federal Register in
interest (PAI) for social development Administration, 5630 Fishers Lane, rm. accordance with 21 CFR 25.51(b).
projects changed. The Administration 1061, Rockville, MD 20852. Submit
for Children and Families has expanded Dated: December 31, 2007.
electronic comments to: http://
the focus of healthy marriage to include Bernadette Dunham,
www.fda.gov/dockets/ecomments.
responsible fatherhood activities. In Deputy Director, Center for Veterinary
FOR FURTHER INFORMATION CONTACT: Medicine.
order to eliminate redundancy, this
activity was added to the NAHMI PA. Isabel W. Pocurull, Center for Veterinary [FR Doc. E8–316 Filed 1–10–08; 8:45 am]
The grandparents PAI was included to Medicine, Food and Drug
BILLING CODE 4160–01–S
promote inter-generational programs. Administration, 7519 Standish Pl.,
(Legal authority: Section 803(a) and (d) Rockville, MD 20855, 240 453–6853,
and 803C of the Native American email: isabel.pocurull@fda.hhs.gov. DEPARTMENT OF HEALTH AND
Programs Act of 1974, as amended, 42 SUPPLEMENTARY INFORMATION: Under the HUMAN SERVICES
U.S.C. 2991b and 2991b–3.) Federal Food, Drug, and Cosmetic Act
The FY 2008 PA will replace the (section 409(b)(5) (21 U.S.C. 348(b)(5))), Food and Drug Administration
fatherhood PAI with the following: notice is given that a food additive
• Projects that address the needs of petition (FAP 2258) has been filed by Anti-Infective Drugs Advisory
grandparents raising grandchildren. Kristi O. Smedley, Center for Regulatory Committee; Notice of Meeting
(D) ANA Mitigation: The FY 2008 PA Services, Inc., 5200 Wolf Run Shoals AGENCY: Food and Drug Administration,
removes all definitions related to in- Rd., Woodbridge, VA 22192–5755, HHS.
kind contributions, including in-kind United States agent for Kemira Oyi, ACTION: Notice.
contributions, leveraged resources, Porkkalantatu 3, PO Box 330, 001000
partnerships, and letters of Helsinki, Finland. The petition proposes This notice announces a forthcoming
commitment. Furthermore, the required to amend the food additive regulations meeting of a public advisory committee
number of impact indicators is reduced in part 573—Food Additives Permitted of the Food and Drug Administration
to one. These changes are reflective of in Feed and Drinking Water of Animals (FDA). The meeting will be open to the
Public Law 103–335 which does not (21 CFR part 573) to provide for the safe public.
require matching funds. (Legal use of partially ammoniated formic acid Name of Committee: Anti-Infective
ebenthall on PRODPC61 with NOTICES

authority: Section 803(a) and (d) and as a pH control agent in swine feed Drugs Advisory Committee.
803C of the Native American Programs when used at levels up to 1.2 percent of General Function of the Committee:
Act of 1974, as amended, 42 U.S.C. the feed. To provide advice and
2991b and 2991b–3 and Public Law The potential environmental impact recommendations to the agency on
103–335.) of this action is being reviewed. To FDA’s regulatory issues.

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2056 Federal Register / Vol. 73, No. 8 / Friday, January 11, 2008 / Notices

Date and Time: The meeting will be be scheduled between approximately 11 as amended. The grant applications and
held on February 27 and 28, 2008, from a.m. and 12 noon. Those desiring to the discussions could disclose
8 a.m. to 5 p.m. make formal oral presentations should confidential trade secrets or commercial
Location: Crowne Plaza Silver Spring, notify the contact person and submit a property such as patentable material,
The Ballrooms, 8777 Georgia Ave., brief statement of the general nature of and personal information concerning
Silver Spring, MD, 301–589–0800. the evidence or arguments they wish to individuals associated with the grant
Contact Person: Sohail Mosaddegh, present, the names and addresses of applications, the disclosure of which
Center for Drug Evaluation and Research proposed participants, and an would constitute a clearly unwarranted
(HFD–21), Food and Drug indication of the approximate time invasion of personal privacy.
Administration, 5600 Fishers Lane (for requested to make their presentation on Name of Committee: National Cancer
express delivery, 5630 Fishers Lane, rm. or before February 4, 2008. Time Institute Initial Review Group, Subcommittee
1093), Rockville, MD 20857, 301–827– allotted for each presentation may be J—Population and Patient-Oriented Training.
7001, FAX: 301–827–6776, e-mail: limited. If the number of registrants Date: February 13, 2008.
sohail.mosaddegh@fda.hhs.gov, or FDA requesting to speak is greater than can Time: 7:45 a.m. to 6 p.m.
Advisory Committee Information Line, be reasonably accommodated during the Agenda: To review and evaluate grant
1–800–741–8138 (301–443–0572 in the scheduled open public hearing session, applications.
Washington, DC area), code FDA may conduct a lottery to determine Place: The Westin Arlington Gateway, 801
3014512530. Please call the Information the speakers for the scheduled open North Glebe Road, Arlington, VA 22203.
Line for up-to-date information on this public hearing session. The contact Contact Person: Ilda M. McKenna, PhD,
meeting. A notice in the Federal Scientific Review Administrator, Research
person will notify interested persons Training Review Branch, Division of
Register about last minute modifications regarding their request to speak by
that impact a previously announced Extramural Activities, National Cancer
February 5, 2008. Institute, 6116 Executive Boulevard, Room
advisory committee meeting cannot Persons attending FDA’s advisory 8111, Bethesda, MD 20892, 301–496–7481,
always be published quickly enough to committee meetings are advised that the mckennai@mail.nih.gov.
provide timely notice. Therefore, you agency is not responsible for providing
should always check the agency’s Web (Catalogue of Federal Domestic Assistance
access to electrical outlets. Program Nos. 93.392, Cancer Construction;
site and call the appropriate advisory FDA welcomes the attendance of the 93.393, Cancer Cause and Prevention
committee hot line/phone line to learn public at its advisory committee Research; 93.394, Cancer Detection and
about possible modifications before meetings and will make every effort to Diagnosis Research; 93.395, Cancer
coming to the meeting. accommodate persons with physical Treatment Research; 93.396, Cancer Biology
Agenda: On February 27, 2008, the disabilities or special needs. If you Research; 93.397, Cancer Centers Support;
committee will discuss new drug require special accommodations due to 93.398, Cancer Research Manpower; 93.399,
application (NDA) 022–110, telavancin a disability, please contact Sohail Cancer Control, National Institutes of Health,
powder for reconstitution and Mosaddegh at least 7 days in advance of HHS)
intravenous administration, Theravance, the meeting.
Inc., proposed for the treatment of Dated: January 4, 2008.
FDA is committed to the orderly
complicated skin and skin structure Jennifer Spaeth,
conduct of its advisory committee
infection. On February 28, 2008, the meetings. Please visit our Web site at Director, Office of Federal Advisory
committee will discuss NDA 022–132, Committee Policy.
http://www.fda.gov/oc/advisory/
ceftobiprole medocaril (500 milligrams), default.htm for procedures on public [FR Doc. 08–64 Filed 1–10–08; 8:45 am]
lyophilized powder for reconstitution conduct during advisory committee BILLING CODE 4140–01–M
and intravenous administration, meetings.
Johnson and Johnson Pharmaceutical Notice of this meeting is given under
Research and Development, LLC, the Federal Advisory Committee Act (5 DEPARTMENT OF HEALTH AND
proposed for the treatment of U.S.C. app. 2). HUMAN SERVICES
complicated skin and skin structure
infection. Dated: January 7, 2008. National Institutes of Health
FDA intends to make background Randall W. Lutter,
material available to the public no later Deputy Commissioner for Policy. National Center for Research
than 2 business days before the meeting. [FR Doc. E8–343 Filed 1–10–08; 8:45 am] Resources; Notice of Closed Meeting
If FDA is unable to post the background BILLING CODE 4160–01–S
material on its Web site prior to the Pursuant to section 10(d) of the
meeting, the background material will Federal Advisory Committee Act, as
be made publicly available at the DEPARTMENT OF HEALTH AND amended (5 U.S.C. Appendix 2), notice
location of the advisory committee HUMAN SERVICES is hereby given of the following
meeting, and the background material meeting.
will be posted on FDA’s Web site after National Institutes of Health The meeting will be closed to the
the meeting. Background material is public in accordance with the
National Cancer Institute; Notice of provisions set forth in sections
available at http://www.fda.gov/ohrms/
Closed Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the Pursuant to section 10(d) of the as amended. The grant applications and
appropriate advisory committee link. Federal Advisory Committee Act, as the discussions could disclose
Procedure: Interested persons may amended (5 U.S.C. Appendix 2), notice confidential trade secrets or commercial
present data, information, or views, is hereby given of the following property such as patentable material,
ebenthall on PRODPC61 with NOTICES

orally or in writing, on issues pending meeting. and personal information concerning


before the committee. Written The meeting will be closed to the individuals associated with the grant
submissions may be made to the contact public in accordance with the applications, the disclosure of which
person on or before February 12, 2008. provisions set forth in sections would constitute a clearly unwarranted
Oral presentations from the public will 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy.

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