Availability of Draft NTP Technical Reports; Request for Comments; Announcement of a Public Meeting To Peer Review Draft NTP Technical Reports, 77832-77833 [2011-32106]

Download as PDF 77832 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices scheduled for peer review by an NTP Technical Reports Peer-Review Panel at a meeting on February 8–9, 2012. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ‘‘Request for Comments’’ below). Information about this meeting, including draft reports and preliminary agenda, will be available on the NTP Web site (https:// ntp.niehs.nih.gov/go/36051). Summary minutes from the peer review will be posted on the NTP Web site following the meeting. SCHEDULE OF MATCHING FUND SUB- DATES: The meeting will be held on MISSION DATES AND DATES TO SUB- February 8–9, 2012. The draft NTP TRs MIT REVISED STATEMENTS OF NET should be available for public comment OUTSTANDING CAMPAIGN OBLIGA- by December 19, 2011. The deadline to TIONS (NOCO) FOR 2012 PRESI- submit written comments is January 25, 2012, and the deadline for preDENTIAL CANDIDATES registration to attend the meeting and/ or provide oral comments at the meeting Matching fund Revised NOCO is February 1, 2012. submission dates submission dates ADDRESSES: The meeting will be held at January 3, 2012 ......... December 23, 2011. the Rodbell Auditorium, Rall Building, February 1, 2012 ........ January 25, 2012. NIEHS, 111 T.W. Alexander Drive, March 1, 2012 ............ February 23, 2012. Research Triangle Park, NC 27709. April 2, 2012 ............... March 26, 2012. Public comments and any other May 1, 2012 ............... April 24, 2012. correspondence on the draft TRs should June 1, 2012 .............. May 24, 2012. be sent to Danica Andrews, Designated July 2, 2012 ................ June 25, 2012. Federal Official, Office of Liaison, August 1, 2012 ........... July 25, 2012. September 4, 2012 ..... August 27, 2012. Policy and Review, Division of the NTP, October 1, 2012 ......... September 24, 2012. NIEHS, P.O. Box 12233, MD K2–03, November 1, 2012 ...... October 25, 2012. Research Triangle Park, NC 27709, FAX: December 3, 2012 ...... November 26, 2012. (919) 541–0295, or January 2, 2013 ......... December 24, 2012. andrewsda@niehs.nih.gov. Courier February 1, 2013 ........ January 25, 2013. address: 530 Davis Drive, Room 2136, March 1, 2013 ............ February 22, 2013. Morrisville, NC 27560. Persons needing interpreting services in order to attend On behalf of the Commission. should contact (301) 402–8180 (voice) Dated: December 8, 2011. or (301) 435–1908 (TTY). Requests Cynthia L. Bauerly, should be made at least five business Chair, Federal Election Commission. days in advance of the meeting. [FR Doc. 2011–31996 Filed 12–13–11; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 6715–01–P Danica Andrews, Designated Federal Official, (919) 541–2595, andrewsda@niehs.nih.gov. DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: HUMAN SERVICES Preliminary Agenda Topics and Availability of Draft NTP Technical Availability of Meeting Materials Reports; Request for Comments; The agenda topic is the peer review of Announcement of a Public Meeting To the findings and conclusions of draft Peer Review Draft NTP Technical NTP TRs of toxicology and Reports carcinogenesis studies in conventional or genetically modified rodent models. AGENCY: National Toxicology Program The preliminary agenda listing the draft (NTP), National Institute of reports and electronic files (PDF) of the Environmental Health Sciences draft reports should be available on the (NIEHS), National Institutes of Health, NTP Web site by December 19, 2011. HHS. Any additional information, when ACTION: Availability of Draft Reports; available, will be posted on the NTP Request for Comments; and Web site (https://ntp.niehs.nih.gov/go/ Announcement of a Public Meeting. 36051) or may be requested in hardcopy SUMMARY: The NTP announces the from the Designated Federal Official availability of seven draft NTP (see ADDRESSES above). Following the Technical Reports (TRs) tentatively meeting, summary minutes will be mstockstill on DSK4VPTVN1PROD with NOTICES each change in the committee’s assets and obligations from the most recent NOCO statement. 11 CFR 9034.5(f)(2). The Commission will review the revised NOCO statement and adjust the committee’s certification to reflect any change in the committee’s financial position that occurs after submission of the matching payment request and the date of the revised NOCO statement. The following schedule includes both matching fund submission dates and submission dates for revised NOCO statements. VerDate Mar<15>2010 19:11 Dec 13, 2011 Jkt 226001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 prepared and made available on the NTP Web site. Information about the NTP testing program is found at https://ntp.niehs.nih.gov/go/test. Attendance and Registration The meeting is scheduled for February 8–9, 2012, from 8:30 a.m. EST to adjournment at approximately 4:30 p.m. on February 8 and approximately noon on February 9 and is open to the public with attendance limited only by the space available. Individuals who plan to attend are encouraged to register online at the NTP Web site (https:// ntp.niehs.nih.gov/go/36051) by February 1, 2012, to facilitate access to the NIEHS campus. A photo ID is required to access the NIEHS campus. The NTP is making plans to webcast the meeting at https://www.niehs.nih.gov/ news/video/live. Registered attendees are encouraged to access the meeting page to stay abreast of the most current information regarding the meeting. Request for Comments The NTP invites written comments on the draft reports, which should be received by January 25, 2012, to enable review by the peer-review panel and NTP staff prior to the meeting. Persons submitting written comments should include their name, affiliation, mailing address, phone, email, and sponsoring organization (if any) with the document. Written comments received in response to this notice will be posted on the NTP Web site, and the submitter will be identified by name, affiliation, and/or sponsoring organization. Public input at this meeting is also invited, and time is set aside for the presentation of oral comments on the draft reports. In addition to in-person oral comments at the meeting at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The available lines will be open from 8 a.m. until adjournment on February 8 and 9, although public comments will be received only during the formal public comment period for each draft report. Each organization is allowed one time slot per draft report. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the chair. Persons wishing to make an oral presentation are asked to register via online registration at https://ntp.niehs.nih.gov/go/36051, phone, or email (see ADDRESSES above) by February 1, 2012, and if possible, to send a copy of the statement or talking points at that time to Ms. Andrews. Written statements can supplement and E:\FR\FM\14DEN1.SGM 14DEN1 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices may expand the oral presentation. Registration for oral comments will also be available at the meeting, although time allowed for presentation by on-site registrants may be less than that for preregistered speakers and will be determined by the number of persons who register on-site. Background Information on NTP Panels NTP panels are technical, scientific advisory bodies established on an ‘‘as needed’’ basis to provide independent scientific peer review and to advise the NTP on agents of public health concern, new/revised toxicological test methods, or other issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening. The NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide a current curriculum vita to Ms. Andrews (see ADDRESSES). The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service (PHS) Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: December 7, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–32106 Filed 12–13–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on CYP2C19 Variants and Platelet Reactivity Tests Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of CYP2C19 variants and platelet reactivity tests. Scientific information is being solicited to inform our Comparative Effectiveness Review of Testing of CYP2C19 Variants and SUMMARY: VerDate Mar<15>2010 15:14 Dec 13, 2011 Jkt 226001 Platelet Reactivity for Guiding Antiplatelet Treatment, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173. DATES: Submission Deadline on or before January 13, 2012. ADDRESSES: Online submissions: https:// effectivehealthcare.AHRQ.gov/index. cfm/submit-scientific-informationpackets/. Please select the study for which you are submitting information from the list of current studies and complete the form to upload your documents. Email submissions: ehcsrc@ohsu.edu (please do not send zipped files—they are automatically deleted for security reasons). Print submissions: Robin Paynter, Oregon Health and Science University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239–3098. FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: (503) 494–0147 or Email: ehcsrcohsu.edu. SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidence-based Practice Centers to complete a comparative effectiveness review of the evidence for testing of CYP2C19 variants and platelet reactivity for guiding antiplatelet treatment. The EHC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by systematically requesting information (e.g., details of studies conducted) from medical device industry stakeholders through public information requests, including via the Federal Register and direct postal and/ or online solicitations. We are looking for studies that report on CYP2C19 variants and platelet reactivity tests, including those that describe adverse PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 77833 events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: https://effective healthcare.AHRQ.gov/index.cfm/ search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&product id=854#3962. This notice is a request for industry stakeholders to submit the following: • A current product label, if applicable (preferably an electronic PDF file). • Information identifying published randomized controlled trials and observational studies relevant to the clinical outcomes. Please provide both a list of citations and reprints if possible. • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes. If possible, please provide a summary that includes the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results. • Registered ClinicalTrials.gov studies. Please provide a list including the ClinicalTrials.gov identifier, condition, and intervention. Your contribution is very beneficial to this program. AHRQ is not requesting and will not consider marketing material, health economics information, or information on other indications. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. In addition to your scientific information please submit an index document outlining the relevant information in each file along with a statement regarding whether or not the submission comprises all of the complete information available. Please Note: The contents of all submissions, regardless of format, will be available to the public upon request unless prohibited by law.The draft of this review will be posted on AHRQ’s EHC program Web site and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://effectivehealth care.AHRQ.gov/index.cfm/join-the-emaillist1/. The Key Questions Key Question 1 In patient populations who are candidates for clopidogrel therapy, does E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77832-77833]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Availability of Draft NTP Technical Reports; Request for 
Comments; Announcement of a Public Meeting To Peer Review Draft NTP 
Technical Reports

AGENCY: National Toxicology Program (NTP), National Institute of 
Environmental Health Sciences (NIEHS), National Institutes of Health, 
HHS.

ACTION: Availability of Draft Reports; Request for Comments; and 
Announcement of a Public Meeting.

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

SUMMARY: The NTP announces the availability of seven draft NTP 
Technical Reports (TRs) tentatively scheduled for peer review by an NTP 
Technical Reports Peer-Review Panel at a meeting on February 8-9, 2012. 
The meeting is open to the public with time scheduled for oral public 
comment. The NTP also invites written comments on the draft reports 
(see ``Request for Comments'' below). Information about this meeting, 
including draft reports and preliminary agenda, will be available on 
the NTP Web site (https://ntp.niehs.nih.gov/go/36051). Summary minutes 
from the peer review will be posted on the NTP Web site following the 
meeting.

DATES: The meeting will be held on February 8-9, 2012. The draft NTP 
TRs should be available for public comment by December 19, 2011. The 
deadline to submit written comments is January 25, 2012, and the 
deadline for pre-registration to attend the meeting and/or provide oral 
comments at the meeting is February 1, 2012.

ADDRESSES: The meeting will be held at the Rodbell Auditorium, Rall 
Building, NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 
27709. Public comments and any other correspondence on the draft TRs 
should be sent to Danica Andrews, Designated Federal Official, Office 
of Liaison, Policy and Review, Division of the NTP, NIEHS, P.O. Box 
12233, MD K2-03, Research Triangle Park, NC 27709, FAX: (919) 541-0295, 
or andrewsda@niehs.nih.gov. Courier address: 530 Davis Drive, Room 
2136, Morrisville, NC 27560. Persons needing interpreting services in 
order to attend should contact (301) 402-8180 (voice) or (301) 435-1908 
(TTY). Requests should be made at least five business days in advance 
of the meeting.

FOR FURTHER INFORMATION CONTACT: Danica Andrews, Designated Federal 
Official, (919) 541-2595, andrewsda@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

    The agenda topic is the peer review of the findings and conclusions 
of draft NTP TRs of toxicology and carcinogenesis studies in 
conventional or genetically modified rodent models. The preliminary 
agenda listing the draft reports and electronic files (PDF) of the 
draft reports should be available on the NTP Web site by December 19, 
2011. Any additional information, when available, will be posted on the 
NTP Web site (https://ntp.niehs.nih.gov/go/36051) or may be requested in 
hardcopy from the Designated Federal Official (see ADDRESSES above). 
Following the meeting, summary minutes will be prepared and made 
available on the NTP Web site. Information about the NTP testing 
program is found at https://ntp.niehs.nih.gov/go/test.

Attendance and Registration

    The meeting is scheduled for February 8-9, 2012, from 8:30 a.m. EST 
to adjournment at approximately 4:30 p.m. on February 8 and 
approximately noon on February 9 and is open to the public with 
attendance limited only by the space available. Individuals who plan to 
attend are encouraged to register online at the NTP Web site (https://ntp.niehs.nih.gov/go/36051) by February 1, 2012, to facilitate access 
to the NIEHS campus. A photo ID is required to access the NIEHS campus. 
The NTP is making plans to webcast the meeting at https://www.niehs.nih.gov/news/video/live. Registered attendees are encouraged 
to access the meeting page to stay abreast of the most current 
information regarding the meeting.

Request for Comments

    The NTP invites written comments on the draft reports, which should 
be received by January 25, 2012, to enable review by the peer-review 
panel and NTP staff prior to the meeting. Persons submitting written 
comments should include their name, affiliation, mailing address, 
phone, email, and sponsoring organization (if any) with the document. 
Written comments received in response to this notice will be posted on 
the NTP Web site, and the submitter will be identified by name, 
affiliation, and/or sponsoring organization.
    Public input at this meeting is also invited, and time is set aside 
for the presentation of oral comments on the draft reports. In addition 
to in-person oral comments at the meeting at the NIEHS, public comments 
can be presented by teleconference line. There will be 50 lines for 
this call; availability will be on a first-come, first-served basis. 
The available lines will be open from 8 a.m. until adjournment on 
February 8 and 9, although public comments will be received only during 
the formal public comment period for each draft report. Each 
organization is allowed one time slot per draft report. At least 7 
minutes will be allotted to each speaker, and if time permits, may be 
extended to 10 minutes at the discretion of the chair. Persons wishing 
to make an oral presentation are asked to register via online 
registration at https://ntp.niehs.nih.gov/go/36051, phone, or email (see 
ADDRESSES above) by February 1, 2012, and if possible, to send a copy 
of the statement or talking points at that time to Ms. Andrews. Written 
statements can supplement and

[[Page 77833]]

may expand the oral presentation. Registration for oral comments will 
also be available at the meeting, although time allowed for 
presentation by on-site registrants may be less than that for pre-
registered speakers and will be determined by the number of persons who 
register on-site.

Background Information on NTP Panels

    NTP panels are technical, scientific advisory bodies established on 
an ``as needed'' basis to provide independent scientific peer review 
and to advise the NTP on agents of public health concern, new/revised 
toxicological test methods, or other issues. These panels help ensure 
transparent, unbiased, and scientifically rigorous input to the program 
for its use in making credible decisions about human hazard, setting 
research and testing priorities, and providing information to 
regulatory agencies about alternative methods for toxicity screening. 
The NTP welcomes nominations of scientific experts for upcoming panels. 
Scientists interested in serving on an NTP panel should provide a 
current curriculum vita to Ms. Andrews (see ADDRESSES). The authority 
for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public 
Health Service (PHS) Act, as amended. The panel is governed by the 
Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which 
sets forth standards for the formation and use of advisory committees.

    Dated: December 7, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-32106 Filed 12-13-11; 8:45 am]
BILLING CODE 4140-01-P

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