Genes and Environment Initiative (GEI)-Exposure Biology Program; GEI-Exposure Biology RFA Application Information Meeting, 60159-60160 [E6-16858]

Download as PDF Federal Register / Vol. 71, No. 197 / Thursday, October 12, 2006 / Notices regulatory expectations and to promote voluntary compliance with current FDA requirements. Submit written or electronic comments on agency guidances at any time. DATES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: Paul W. Haynie, Center for Drug Evaluation and Research (HFD–327), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301–827– 9020. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: rwilkins on PROD1PC63 with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.’’ This guidance document provides guidance to the pharmaceutical industry on investigation of laboratory results that fall outside of specification limits. The guidance addresses investigations of OOS results in the laboratory phase, including responsibilities of the analyst and supervisor, and when indicated, the expansion of an investigation outside of the laboratory to include production processes, and raw materials as appropriate. This guidance is intended to apply to traditional methods of drug product testing and release, based on testing of discrete samples of in-process materials and finished products. The guidance is not intended to address process analytical technology, as routine in-process use of these methods might include other considerations. The agency, in accordance with its August 2002 ‘‘Pharmaceutical CGMPs for the 21st Century’’ initiative, encourages modern approaches to manufacturing, monitoring, and control to enhance process predictability and efficiency. The use of continuous on-line testing VerDate Aug<31>2005 16:21 Oct 11, 2006 Jkt 211001 technologies will be addressed in other agency guidance. In the Federal Register of September 30, 1998 (63 FR 52276), FDA announced the availability of a draft guidance of the same title and gave interested persons an opportunity to submit comments by November 30, 1998. The agency received public comments from a broad spectrum of the pharmaceutical industry. In response to comments received on the draft guidance, the agency made the following changes: (1) Revised the scope and background sections to clarify the applicability of the document, (2) reorganized the sections on investigating OOS results, averaging, and concluding the investigation, and (3) clarified or added more specific guidance on certain issues. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on investigating OOS test results for pharmaceutical production. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. 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. 60159 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Genes and Environment Initiative (GEI)—Exposure Biology Program; GEI—Exposure Biology RFA Application Information Meeting National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), DHHS. ACTION: Notice. AGENCY: SUMMARY: An Application Information Meeting, hosted by the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Drug Abuse (NIDA), will be held on October 20, 2006, on the NIEHS campus in Research Triangle Park, North Carolina. The meeting will include an overview of the Exposure Biology Program, presentations on the five funding opportunities, an overview of the cooperative agreement mechanism and Grants Management and Review issues, and a question and answer session addressing RFA-related questions. DATES: October 20, 2006. ADDRESSES: The GEI-Exposure Biology Program RFA Application Information meeting will be held at the National Institute of Environmental Health Sciences, 111 TW Alexander Drive, Research Triangle Park, North Carolina [Rall Building (Building 101), Rodbell B]. Information on the meeting will be posted on the GEI-Exposure Biology Web site at https://www.gei.nih.gov/ exposurebiology/index.asp. FOR FURTHER INFORMATION CONTACT: Anne Thompson, NIEHS, P.O. Box 12233, MD B2–01, Research Triangle Park, NC 27709; telephone: 919–316– 4517, or e-mail: thomps13@niehs.nih.gov. SUPPLEMENTARY INFORMATION: III. Electronic Access Preliminary Agenda Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. GEI-Exposure Biology RFA Application Information Meeting, October 20, 2006, National Institute of Environmental Health Sciences, Rall Building (Bldg. 101), Rodbell B, 111 TW Alexander Drive, Research Triangle Park, NC 27709. 1–1:20 p.m. Exposure Biology Program Overview—Brenda Weis (NIEHS). 1:20–1:50 p.m. Biological Response Indicators of Environmental Stress RFAs (U01 and U54)—Sally Tinkle (NIEHS). Dated: October 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–16838 Filed 10–11–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1 60160 Federal Register / Vol. 71, No. 197 / Thursday, October 12, 2006 / Notices 1:50–2:10 p.m. Environmental Sensors for Personal Exposure Assessment RFA (U01)—David Balshaw (NIEHS). 2:10–2:30 p.m. Improved Measures of Diet and Physical Activity RFA (U01)—Amy Subar/Cay Loria (NCI/ NHLBI). 2:30–2:50 p.m. Field-Deployable Tools for Quantifying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease RFA (U01)— Kay Wanke/Kevin Conway (NIDA). 2:50–3:10 p.m. Overview of the ‘‘U’’ Mechanism and the Review and Grants Management Process—Gwen Collman (NIEHS). 3:10–3:25 p.m. General Open Discussion and Questions—Everyone. 3:25–3:35 p.m. Break to One-on-One Sessions. 3:35–4 p.m. One-on-One Session— General Q&A. 4–5:30 p.m. One-on-One Session— Individual Q&A. Attendance, Registration, and Remote Access The meeting is being held on October 20, 2006, from 1–5:30 p.m. Individuals who plan on attending either in person or by videocast should register on the GEI-Exposure Biology Web site at https://fmp-8.cit.nih.gov/gei/ register.html. A map of the NIEHS campus, including visitor parking, is available at https://www.niehs.nih.gov/ external/contact.htm. Please note that a photo ID is required to access the NIEHS campus. Individuals with disabilities, who need Sign Language Interpreters and/or reasonable accommodation to participate in this event, should contact 919–541–2475 voice, 919–541–4644 TTY, through the Federal TTY Relay System at 800–877–8339, or by e-mail: niehsoeeo@niehs.nih.gov. Requests should be made at least 5 days in advance of the event. rwilkins on PROD1PC63 with NOTICES Availability of Meeting Materials Meeting details will be posted on the GEI-Exposure Biology Web site at https://www.gei.nih.gov/ exposurebiology/meetings/appinfo06/. Following the meeting, a recorded videocast of the meeting will be made available on the Web site. Background Information on the Exposure Biology Program The Genes and Environment Initiative (GEI) is a four-year, NIH-wide program, which aims to accelerate understanding of genetic and environmental contributions to health and disease. The GEI is comprised of two components— the Genetics Program being led by VerDate Aug<31>2005 16:21 Oct 11, 2006 Jkt 211001 NHGRI and the Exposure Biology Program being led by NIEHS. The Exposure Biology Program will focus on the development of innovative technologies to measure environmental exposures, diet, physical activity, psychosocial stress, and addictive substances that contribute to the development of disease. The program will support: (1) Development of environmental sensors for measurement of chemicals, dietary intake, physical activity, and psychosocial stressors and addictive substances; (2) development of markers of biological response via common pathogenic mechanisms such as oxidative stress, epigenetic modifications, and DNA damage; (3) integration of biological responses with the development of biosensors; and (4) application of novel assays and biomarkers to GWA studies of geneenvironment interaction. This will be accomplished through the use of five cooperative agreements (RFAs) led by three NIH Institutes (NIEHS, NIDA, and NCI/NHLBI). Further information on the GEI-Exposure Biology Program can be found on the GEI-Exposure Biology Web site at: https://www.gei.nih.gov/ exposurebiology/index.asp. Dated: October 4, 2006. David A. Schwartz, Director, National Institute of Environmental Health Sciences, National Institutes of Health. [FR Doc. E6–16858 Filed 10–11–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Preparedness Directorate; Proposed Collection; Comment Request; FY03 Domestic Preparedness Program— State and Local Survey Preparedness Directorate, National Preparedness Task Force (NPTF), Department of Homeland Security (DHS). ACTION: 60-day notice and request for comments. AGENCY: SUMMARY: The Preparedness Directorate invites the general public and other Federal agencies the opportunity to comment on the reinstatement of a previously approved information collection request (ICR) OMB 1651– 0101 FY03 Domestic Preparedness Program, State and Local Survey. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995, (Pub. L. 104–13, 44 U.S.C. chapter 35) as amended by the ClingerCohen Act (Pub. L. 104–106). PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Written comments should be received on or before December 11, 2006 to be assured consideration. ADDRESSES: Direct all written comments to the Preparedness Directorate, NPTF, Attn. Sharon Kushnir, 3801 Nebraska Avenue Complex, Building 3, Washington, DC 20528. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to the Preparedness Directorate, NPTF, Attn.: Sharon Kushnir, 3801 Nebraska Avenue Complex, Building 3, Washington, DC 20528, Tel. (202) 282–9680 or by electronic mail (e-mail) to: Sharon.kushnir@dhs.gov. DATES: The Preparedness Directorate invites the general public and other Federal Agencies to comment on proposed and/ or continuing information collections pursuant to the Paperwork Reduction Act of 1995, (Pub. L. 104–13, 44 U.S.C. chapter 35) as amended by the ClingerCohen Act (Pub. L. 104–106). Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. The comments that are submitted will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document the Preparedness Directorate is soliciting comments concerning the following information collection: SUPPLEMENTARY INFORMATION: Analysis Agency: Preparedness Directorate, National Preparedness Task Force E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 71, Number 197 (Thursday, October 12, 2006)]
[Notices]
[Pages 60159-60160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Genes and Environment Initiative (GEI)--Exposure Biology Program; 
GEI--Exposure Biology RFA Application Information Meeting

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), DHHS.

ACTION: Notice.

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

SUMMARY: An Application Information Meeting, hosted by the National 
Institute of Environmental Health Sciences (NIEHS), the National Cancer 
Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), 
and the National Institute on Drug Abuse (NIDA), will be held on 
October 20, 2006, on the NIEHS campus in Research Triangle Park, North 
Carolina. The meeting will include an overview of the Exposure Biology 
Program, presentations on the five funding opportunities, an overview 
of the cooperative agreement mechanism and Grants Management and Review 
issues, and a question and answer session addressing RFA-related 
questions.

DATES: October 20, 2006.

ADDRESSES: The GEI-Exposure Biology Program RFA Application Information 
meeting will be held at the National Institute of Environmental Health 
Sciences, 111 TW Alexander Drive, Research Triangle Park, North 
Carolina [Rall Building (Building 101), Rodbell B]. Information on the 
meeting will be posted on the GEI-Exposure Biology Web site at https://
www.gei.nih.gov/exposurebiology/index.asp.

FOR FURTHER INFORMATION CONTACT: Anne Thompson, NIEHS, P.O. Box 12233, 
MD B2-01, Research Triangle Park, NC 27709; telephone: 919-316-4517, or 
e-mail: thomps13@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Preliminary Agenda

    GEI-Exposure Biology RFA Application Information Meeting, October 
20, 2006, National Institute of Environmental Health Sciences, Rall 
Building (Bldg. 101), Rodbell B, 111 TW Alexander Drive, Research 
Triangle Park, NC 27709.

1-1:20 p.m. Exposure Biology Program Overview--Brenda Weis (NIEHS).
1:20-1:50 p.m. Biological Response Indicators of Environmental Stress 
RFAs (U01 and U54)--Sally Tinkle (NIEHS).

[[Page 60160]]

1:50-2:10 p.m. Environmental Sensors for Personal Exposure Assessment 
RFA (U01)--David Balshaw (NIEHS).
2:10-2:30 p.m. Improved Measures of Diet and Physical Activity RFA 
(U01)--Amy Subar/Cay Loria (NCI/NHLBI).
2:30-2:50 p.m. Field-Deployable Tools for Quantifying Exposures to 
Psychosocial Stress and to Addictive Substances for Studies of Health 
and Disease RFA (U01)--Kay Wanke/Kevin Conway (NIDA).
2:50-3:10 p.m. Overview of the ``U'' Mechanism and the Review and 
Grants Management Process--Gwen Collman (NIEHS).
3:10-3:25 p.m. General Open Discussion and Questions--Everyone.
3:25-3:35 p.m. Break to One-on-One Sessions.
3:35-4 p.m. One-on-One Session--General Q&A.
4-5:30 p.m. One-on-One Session--Individual Q&A.

Attendance, Registration, and Remote Access

    The meeting is being held on October 20, 2006, from 1-5:30 p.m. 
Individuals who plan on attending either in person or by videocast 
should register on the GEI-Exposure Biology Web site at https://fmp-
8.cit.nih.gov/gei/register.html. A map of the NIEHS campus, including 
visitor parking, is available at https://www.niehs.nih.gov/external/
contact.htm. Please note that a photo ID is required to access the 
NIEHS campus. Individuals with disabilities, who need Sign Language 
Interpreters and/or reasonable accommodation to participate in this 
event, should contact 919-541-2475 voice, 919-541-4644 TTY, through the 
Federal TTY Relay System at 800-877-8339, or by e-mail: 
niehsoeeo@niehs.nih.gov. Requests should be made at least 5 days in 
advance of the event.

Availability of Meeting Materials

    Meeting details will be posted on the GEI-Exposure Biology Web site 
at https://www.gei.nih.gov/exposurebiology/meetings/appinfo06/. 
Following the meeting, a recorded videocast of the meeting will be made 
available on the Web site.

Background Information on the Exposure Biology Program

    The Genes and Environment Initiative (GEI) is a four-year, NIH-wide 
program, which aims to accelerate understanding of genetic and 
environmental contributions to health and disease. The GEI is comprised 
of two components--the Genetics Program being led by NHGRI and the 
Exposure Biology Program being led by NIEHS. The Exposure Biology 
Program will focus on the development of innovative technologies to 
measure environmental exposures, diet, physical activity, psychosocial 
stress, and addictive substances that contribute to the development of 
disease. The program will support: (1) Development of environmental 
sensors for measurement of chemicals, dietary intake, physical 
activity, and psychosocial stressors and addictive substances; (2) 
development of markers of biological response via common pathogenic 
mechanisms such as oxidative stress, epigenetic modifications, and DNA 
damage; (3) integration of biological responses with the development of 
biosensors; and (4) application of novel assays and biomarkers to GWA 
studies of gene-environment interaction. This will be accomplished 
through the use of five cooperative agreements (RFAs) led by three NIH 
Institutes (NIEHS, NIDA, and NCI/NHLBI). Further information on the 
GEI-Exposure Biology Program can be found on the GEI-Exposure Biology 
Web site at: https://www.gei.nih.gov/exposurebiology/index.asp.

    Dated: October 4, 2006.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences, National 
Institutes of Health.
 [FR Doc. E6-16858 Filed 10-11-06; 8:45 am]
BILLING CODE 4140-01-P

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