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54916 Federal Register / Vol. 72, No.

187 / Thursday, September 27, 2007 / Notices

programs accept applications from and public health management and professional experience, references and
potential candidates for review and leadership. Further benefit from this description of professional goals. The
selection. online application is the reduction of application questions and data collected
The purpose of this project is to duplicate candidate records as well as are necessary to the application process
efficiently and effectively recruit and agency resources to administer and to determine programmatic eligibility
select qualified individuals to process paper records. and to ensure that the most highly
participate in the CDD professional The application process includes the qualified candidates are chosen for the
training programs by collecting following: Submission of the responses training programs.
information through an online to the questions in the online With the exception of their time, the
application management system. application; submission of academic cost to the candidates is minor. One
This online application provides the transcripts, professional credentials, and expense depends on their academic
CDD with the information necessary to letters of recommendation; a review by institutions since they must obtain and
recruit qualified professionals to selected programmatic staff and expert submit all of their academic transcripts.
participate in public health professions panel members; selection of qualified Another expense depends on the cost to
training programs to build critical candidates for interview; interview of obtain and submit other professional
public health workforce capacity in candidates; and selection of trainees for credentials including professional
epidemiology, preventive medicine, programs. licenses and certifications. The final
prevention effectiveness/health The online application questions ask expense is the cost to submit letters of
economics, public health informatics, for demographic data, academic history, recommendation.

ESTIMATED ANNUALIZED BURDEN HOURS


Average burden
Number of Responses per Total burden
Respondents per response
respondents respondent (in hours)
(in hours)

Fellowship and Training Candidates ....................................................... 600 1 1 600

Dated: September 19, 2007. nomination to the committee should regarding scientific issues and
Maryam I. Daneshvar, nominees still be needed. regulatory policies.
Acting Reports Clearance Officer, Centers for ADDRESSES: All Nomination for
Disease Control and Prevention.
II. Criteria for Voting Member
membership should be sent
[FR Doc. E7–19073 Filed 9–26–07; 8:45 am] electronically to CV@FDA.HHS.GOV, or FDA is requesting nominations of
BILLING CODE 4163–18–P by mail to Advisory Committee voting members with appropriate
Oversight & Management Staff, 5600 expertise in the following veterinary
Fisher Lane, HF–4, rm. 15A–12, specialties: companion animal
DEPARTMENT OF HEALTH AND Rockville, MD 20857. medicine, food animal medicine (avian,
HUMAN SERVICES bovine, porcine and minor species),
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for microbial food safety and risk
Food and Drug Administration
membership, the primary contact is assessment, biometrics, toxicology,
Request for Nominations for Voting Aleta Sindelar, Center for Veterinary pathology, pharmacology, animal
Members on Public Advisory Medicine (HFV–6), Food and Drug science, epidemiology.
Committee, Veterinary Medicine Administration, 7519 Standish Pl., III. Nomination Procedures
Advisory Committee Rockville, MD 20855, 240–276–9004,
FAX: 240–276–9020, e-mail: Any interested person may nominate
AGENCY: Food and Drug Administration,
Aleta.Sindelar@FDA.HHS.GOV. one or more qualified persons for
HHS.
Information about becoming a member membership on one the advisory
ACTION: Notice. on a FDA advisory committee can also committee. Self-nominations are also
The Food and Drug Administration be obtained by visiting FDA’s Web site accepted. Nominations shall include the
(FDA) is requesting nominations for by using the following link http:// name of the committee, a complete
voting members to serve on the www.fda.gov/oc/advisory/default.htm. curriculum vitae of each nominee, and
Veterinary Medicine Advisory SUPPLEMENTARY INFORMATION: FDA is their current business address and
Committee (VMAC), Center for requesting nomination for voting telephone number and e-mail address if
Veterinary Medicine (CVM). members on the Veterinary Medicine available. Each nomination shall state
FDA has a special interest in ensuring Advisory Committee. that the nominee is aware of the
that women, minority groups, and nomination, is willing to serve as a
individuals with disabilities are I. Function of the Veterinary Medicine member, and appears to have no conflict
adequately represented on advisory Advisory Committee of interest that would preclude
committees and, therefore, encourages The Committee reviews and evaluates membership. FDA will ask the potential
nominations of qualified candidates available data concerning the safety and candidates to provide detailed
from these groups. effectiveness of marketed and information concerning such matters as
DATES: Nominations received on or investigational new animal drugs, feeds, financial holdings, employment, and
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before October 30, 2007, will be given and devices for use in the treatment and research grants and/or contracts to
first consideration for membership on prevention of animal diseases and permit evaluation of possible sources of
the Veterinary Medicine Advisory increased animal production, and makes conflict of interest.
Committee. Nominations received after appropriate recommendations to the This notice is issued under the
October 30, 2007, will be considered for Commissioner of Food and Drugs Federal Advisory Committee Act (5

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Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices 54917

U.S.C. app.2) and 21 CFR part 14 1061, Rockville, MD 20852. Submit used if such approach satisfies the
relating to advisory committees. electronic comments to either http:// requirements of the applicable statutes
Dated: September 13, 2007. www.fda.gov/dockets/ecomments or and regulations.
Randall W. Lutter, http://www.regulations.gov.
II. Comments
Deputy Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics Interested persons may, at any time,
[FR Doc. E7–19130 Filed 9–26–07; 8:45 am] submit to the Division of Dockets
BILLING CODE 4160–01–S
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401 Management (see ADDRESSES) written or
Rockville Pike, suite 200N, Rockville, electronic comments regarding the
MD 20852–1448, 301–827–6210. guidance. Submit a single copy of
DEPARTMENT OF HEALTH AND
electronic comments or two paper
HUMAN SERVICES SUPPLEMENTARY INFORMATION:
copies of any mailed comments, except
Food and Drug Administration I. Background that individuals may submit one paper
FDA is announcing the availability of copy. Comments are to be identified
[Docket No. 2005D–0155] with the docket number found in the
a document entitled ‘‘Guidance for
Industry: Toxicity Grading Scale for brackets in the heading of this
Guidance for Industry: Toxicity
Healthy Adult and Adolescent document. A copy of the guidance and
Grading Scale for Healthy Adult and
Volunteers Enrolled in Preventive received comments are available for
Adolescent Volunteers Enrolled in
Vaccine Clinical Trials,’’ dated public examination in the Division of
Preventive Vaccine Clinical Trials;
September 2007. The guidance provides Dockets Management between 9 a.m.
Availability
sponsors of vaccine trials with toxicity and 4 p.m., Monday through Friday.
AGENCY: Food and Drug Administration, grading scale tables as a guideline when III. Electronic Access
HHS. selecting the criteria to assess the
ACTION: Notice. severity of clinical and laboratory Persons with access to the Internet
abnormalities in healthy adult and may obtain the guidance at either http://
SUMMARY: The Food and Drug www.fda.gov/cber/guidelines.htm or
Administration (FDA) is announcing the adolescent volunteers enrolled in
clinical trials of a preventive vaccine. http://www.fda.gov/ohrms/dockets/
availability of a document entitled default.htm.
‘‘Guidance for Industry: Toxicity FDA recommends the incorporation of
such appropriate, uniform criteria into Dated: September 20, 2007.
Grading Scale for Healthy Adult and
Adolescent Volunteers Enrolled in the investigational plan, case report Jeffrey Shuren,
Preventive Vaccine Clinical Trials,’’ forms, and study reports and Assistant Commissioner for Policy.
dated September 2007. The guidance correspondence with FDA, sponsors, [FR Doc. E7–19155 Filed 9–26–07; 8:45 am]
document provides sponsors of vaccine monitors, investigators, and BILLING CODE 4160–01–S
trials with recommendations on institutional review boards. The
assessing the severity of clinical and parameters in the tables are not
laboratory abnormalities in healthy necessarily applicable to every clinical
trial of healthy volunteers. The DEPARTMENT OF HOMELAND
adult and adolescent volunteers SECURITY
enrolled in clinical trials. In particular, parameters monitored should be
the guidance includes toxicity grading appropriate for the specific study
vaccine. In addition, the use of toxicity Federal Emergency Management
scale tables to use as a guideline for Agency
selecting the assessment criteria. The grading scales to categorize adverse
guidance announced in this notice events observed during clinical trials [Docket No. FEMA–2007–0008]
finalizes the draft guidance of the same does not replace regulatory
title dated April 2005. requirements to monitor, investigate, National Advisory Council; Notice of
and report adverse events. Federal Advisory Committee Meeting
DATES: Submit written or electronic
In the Federal Register of May 2, 2005
comments on agency guidances at any AGENCY: Federal Emergency
(70 FR 22664), FDA announced the
time. Management Agency, DHS.
availability of the draft guidance of the
ADDRESSES: Submit written requests for same title dated April 2005. FDA ACTION: Notice of Federal Advisory
single copies of the guidance to the received several comments on the draft Committee Meeting.
Office of Communication, Training, and guidance and those comments were
Manufacturers Assistance (HFM–40), considered as the guidance was SUMMARY: This notice announces the
Center for Biologics Evaluation and finalized. A summary of changes date, time, location and agenda for the
Research (CBER), Food and Drug includes: (1) Clarification of the clinical inaugural meeting of the National
Administration, 1401 Rockville Pike, toxicity parameters and (2) revision of Advisory Council (NAC). At the
suite 200N, Rockville, MD 20852–1448. laboratory parameter limit values based meeting, members will be introduced
Send one self-addressed adhesive label on additional published data. The and sworn in and the Chair and Vice
to assist the office in processing your guidance announced in this notice Chair will be introduced. Members will
requests. The guidance may also be finalizes the draft guidance dated April also receive briefings on the status of the
obtained by mail by calling CBER at 1– 2005. reorganized Federal Emergency
800–835–4709 or 301–827–1800. See The guidance is being issued Management Agency (FEMA) and its
the SUPPLEMENTARY INFORMATION section consistent with FDA’s good guidance programs, and to discuss the vision,
for electronic access to the guidance practices regulation (21 CFR 10.115). priorities and structure for the NAC.
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document. The guidance represents FDA’s current The meeting will be open to the public.
Submit written comments on the thinking on this topic. It does not create DATES: Meeting Dates: Monday, October
guidance to the Division of Dockets or confer any rights for or on any person 22, 2007, 9:45 a.m. to 5 p.m. and
Management (HFA–305), Food and Drug and does not operate to bind FDA or the Tuesday, October 23, 2007, 9 a.m. to
Administration, 5630 Fishers Lane, rm. public. An alternative approach may be 4:30 p.m. A public comment period will

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