Anthrax Vaccines-Bridging Correlates of Protection in Animals to Immunogenicity in Humans; Public Workshop, 33508-33509 [E7-11613]

Download as PDF jlentini on PROD1PC65 with NOTICES 33508 Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Notices Policy for state TANF and Adult Assistance topics or the Director, Division of Tribal TANF Management for tribal TANF and NEW topics. 3. The authority to deem state TANF plan amendments complete requires prior consultation with and concurrence of the Director, Division of State TANF Policy. 4. The authority to approve/ disapprove under 45 CFR 205.55(d), state applications to use alternate sources of information for income and eligibility (i.e., IEVS), requires prior consultation with and the concurrence of the Office of the Deputy Assistant Secretary for Administration, the Director, Division of State TANF Policy, and with the other programs affected by the request. 5. The authority to approve/ disapprove under 45 CFR 205.56(a)(1), IEVS targeting plans, requires prior consultation with and the concurrence of the Office of the Deputy Assistance Secretary for Administration and the Director, Division of State TANF Policy. 6. The authority to issue letters to state and tribal TANF grantees acknowledging their success in achieving work participation rates for a fiscal year requires the concurrence of the Director, Division of State TANF Policy for state TANF grantees or the Director, Division of Tribal TANF Management for tribal TANF grantees. 7. The authority to advise and notify state TANF grantees on their caseload reduction credit applications requires prior consultation with the Director, Division of State TANF policy. 8. The authority to request caseload and expenditure data from state TANF grantees relative to establishing a TFAG requires consultation with and concurrence of the Director, Division of Tribal TANF Management. 9. The authority to approve, request changes, or defer action on ‘‘Letters of Intent’’ submitted by tribal applicants who wish to operate TANF programs requires prior consultation with and concurrence of the Director, Division of Tribal TANF Management. 10. The authority to implement TANF technical assistance plans and proposals for the expenditure of technical assistance funds requires approval of the Associate Director, TANF in consultation with the Director, Division of State & Territory Management. 11. The authority to request additional information and consult with states and tribes on modifications to TANF corrective compliance plans requires prior consultation with and concurrence of the Director, Division of State TANF Policy for state TANF plans VerDate Aug<31>2005 18:19 Jun 15, 2007 Jkt 211001 or the Director, Division of Tribal TANF Management for tribal TANF plans. 12. The authority to approve audit resolutions letters requires prior consultation with and the concurrence of the Regional Office Grants Officer and the Director, Division of State TANF Policy for state TANF and Adult Assistance grantees, or the Director, Division of Tribal TANF Management for tribal TANF and NEW grantees. 13. This delegation of authority does not include the authority to make determinations on state appeals concerning audit questions or recommendations by the Department of Health and Human Services (HHS) Audit Agency which involve ACF program practices reviewed under titles I, X, XI, and XVI of the Social Security Act. 14. The authority to approve Adult Assistance Plans and amendments requires prior consultation with and concurrence of the Director, Division of State TANF Policy. 15. The authority to approve FFP in payments for repairs to homes owned by recipients of Adult Assistance requires prior consultation with and concurrence of the Regional Office Grants Officer and Director, Division of State TANF Policy. (c) Effective Date This delegation is effective upon the date of signature. (d) Effect on Existing Delegations As related to the authorities delegated herein, this delegation of authority supersedes all previous delegations of authority to the TANF Regional Program Managers. I hereby affirm and ratify any actions taken by the TANF Regional Office Program Managers, Office of Family Assistance, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: June 8, 2007. Katherine Bradley, Associate Director, TANF. [FR Doc. E7–11707 Filed 6–15–07; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0225] Anthrax Vaccines—Bridging Correlates of Protection in Animals to Immunogenicity in Humans; Public Workshop AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Anthrax Vaccines—Bridging Correlates of Protection in Animals to Immunogenicity in Humans.’’ The purpose of the public workshop is to discuss possible strategies for bridging animal efficacy data to human immunogenicity data for investigational anthrax vaccines. Date and Time: The public workshop will be held on November 8, 2007, from 8:30 a.m. to 5 p.m. and November 9, 2007, from 8:30 a.m. to 1 p.m. Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD, 20877, 1–301–977– 8900. Contact Person: Pier Minor, National Institutes of Health/Office of the Director, 6610 Rockledge Dr., Rm. 5WS6, Mail Stop Code 6604, Bethesda, MD 20892, 301–451–6809, FAX: 301– 402–0659, e-mail: minorp@mail.nih.gov. Registration: Mail or fax your registration information (including name, title, firm name, address, telephone, and fax number) to the contact person by October 19, 2007. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration. If you need special accommodations due to a disability, please contact Wenda Minor (see Contact Person) at least 7 days in advance. SUPPLEMENTARY INFORMATION: FDA’s Center for Biologics Evaluation and Research, in cooperation with the National Institutes of Health and the Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response, is holding this public workshop. The public workshop will include discussions on: (1) Background information on the ‘‘Animal Rule’’ (May 31, 2002, 67 FR 37988), immunological correlates of protection, and the toxin neutralizing assay that will be used to assess anthrax vaccine immunogenicity in animals and humans; (2) animal protection data for anthrax vaccines given both pre- and post-exposure; and (3) human immunogenicity data for anthrax vaccines. The goal of the public workshop is to discuss ways to expedite the development of new anthrax vaccines by providing additional information about bridging animal protection data to human immunogenicity. E:\FR\FM\18JNN1.SGM 18JNN1 Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Notices Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at https://www.fda.gov/cber/ minutes/workshop-min.htm. Dated: June 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–11613 Filed 6–15–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0217] Licensure of Apheresis Blood Products; Public Workshop AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled: Licensure of Apheresis Blood Products. The purpose of the public workshop is to educate industry on the licensure requirements and license application procedures for Platelets, Pheresis; Red Blood Cells; and Plasma collected by automated blood cell separator devices. Date and Time: The public workshop will be held on August 15, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894. Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research(HFM–302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by July 31, 2007. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. VerDate Aug<31>2005 18:19 Jun 15, 2007 Jkt 211001 If you need special accommodations due to a disability, please contact Rhonda Dawson at least 7 days in advance. The public workshop will feature presentations by experts from government and industry. The workshop will include presentations by FDA on: (1) Requirements for licensure, and applicable regulations and guidances, for Platelets, Pheresis; Red Blood Cells; and Plasma (intended for transfusion) collected by apheresis instruments; (2) the FDA managed review process; and (3) failure investigations of apheresis products. Device manufacturers will present an overview of their devices and review validation procedures and quality control processes. Representatives from blood establishments will present case studies of licensing applications. FDA will lead a question and answer session with workshop participants. Comments: All individuals wishing to submit questions to be addressed at the public workshop should submit written or electronic comments by July 31, 2007, to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm.6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at https://www.fda.gov/cber/ minutes/workshop-min.htm. 33509 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency SUPPLEMENTARY INFORMATION: Dated: June 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–11615 Filed 6–15–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Agency Information Collection Activities: Proposed Collection; Comment Request Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. AGENCY: SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revised information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning FEMA’s National Emergency Training Center (NETC) to approve and coordinate the use of the NETC facility for extracurricular training activities. SUPPLEMENTARY INFORMATION: The National Emergency Training Center (NETC) is a FEMA facility that houses the Emergency Management Institute (EMI) and the National Fire Academy (NFA). NETC provides training and educational programs for Federal, State, and local personnel in hazard mitigation, emergency response and preparedness, fire prevention and control, disaster response, and longterm disaster recovery. Special groups sponsored by EMI, NFA or other FEMA organizations may use NETC facilities to conduct activities closely related to and in direct support of their activities. Such groups include other Federal departments and agencies, groups charted by Congress such as the American Red Cross, State and local governments, volunteer groups, and national and international associations representing State and local governments. Collection of Information Title: Approval and Coordination of requirements to use NETC for Extracurricular Training Activities. Type of Information Collection: Revision of an existing collection. OMB Number: 1660–0029. Form Numbers: FEMA Form 75–10, Request for Housing Accommodations, and FEMA Form 75–11, Request for Use of NETC Facility. Abstract: Data will be obtained from special groups that request to use NETC facilities for extracurricular training E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Notices]
[Pages 33508-33509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0225]


Anthrax Vaccines--Bridging Correlates of Protection in Animals to 
Immunogenicity in Humans; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Anthrax Vaccines--Bridging Correlates of Protection 
in Animals to Immunogenicity in Humans.'' The purpose of the public 
workshop is to discuss possible strategies for bridging animal efficacy 
data to human immunogenicity data for investigational anthrax vaccines.
    Date and Time: The public workshop will be held on November 8, 
2007, from 8:30 a.m. to 5 p.m. and November 9, 2007, from 8:30 a.m. to 
1 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD, 20877, 1-301-977-8900.
    Contact Person: Pier Minor, National Institutes of Health/Office of 
the Director, 6610 Rockledge Dr., Rm. 5WS6, Mail Stop Code 6604, 
Bethesda, MD 20892, 301-451-6809, FAX: 301-402-0659, e-mail: 
minorp@mail.nih.gov.
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax number) to the 
contact person by October 19, 2007. There is no registration fee for 
the public workshop. Early registration is recommended because seating 
is limited. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Wenda Minor (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA's Center for Biologics Evaluation and 
Research, in cooperation with the National Institutes of Health and the 
Department of Health and Human Services' Office of Biomedical Advanced 
Research and Development Authority (BARDA) within the Office of the 
Assistant Secretary for Preparedness and Response, is holding this 
public workshop. The public workshop will include discussions on: (1) 
Background information on the ``Animal Rule'' (May 31, 2002, 67 FR 
37988), immunological correlates of protection, and the toxin 
neutralizing assay that will be used to assess anthrax vaccine 
immunogenicity in animals and humans; (2) animal protection data for 
anthrax vaccines given both pre- and post-exposure; and (3) human 
immunogenicity data for anthrax vaccines. The goal of the public 
workshop is to discuss ways to expedite the development of new anthrax 
vaccines by providing additional information about bridging animal 
protection data to human immunogenicity.

[[Page 33509]]

    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11613 Filed 6-15-07; 8:45 am]
BILLING CODE 4160-01-S

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