National Toxicology Program (NTP): Office of Liaison, Policy, and Review; Availability of Draft NTP Technical Reports; Request for Comments; Announcement of a Panel Meeting to Peer Review Draft NTP Technical Reports, 73085-73086 [2010-29945]

Download as PDF Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. John Dahlberg, Director, Division of Investigative Oversight, Office of Research Integrity. [FR Doc. 2010–29867 Filed 11–26–10; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP): Office of Liaison, Policy, and Review; Availability of Draft NTP Technical Reports; Request for Comments; Announcement of a Panel Meeting to Peer Review Draft NTP Technical Reports National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). ACTION: Availability of Draft Reports; Request for Comments; and Announcement of a Meeting. AGENCY: The NTP announces the availability of draft NTP Technical Reports (TRs; available at https:// ntp.niehs.nih.gov/go/36051) that will be peer-reviewed by an NTP Technical Reports Peer Review Panel at a meeting on January 26, 2011. 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). Summary minutes from the peer review will be posted on the NTP Web site following the meeting. DATES: The meeting to review the draft NTP TRs will be held on January 26, 2011. The draft NTP TRs will be available for public comment by December 8, 2010. The deadline to submit written comments is January 12, 2011, and the deadline for preregistration to attend the meeting and/ or provide oral comments at the meeting is January 19, 2011. 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 Dr. Lori White, NIEHS, P.O. Box 12233, MD K2–03, Research Triangle Park, NC 27709, FAX: (919) 541–0295, or whiteld@niehs.nih.gov. Courier address: 530 Davis Drive, Room 2136, Morrisville, NC 27560. Persons needing interpreting services in order to mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:57 Nov 26, 2010 Jkt 223001 attend should contact (301) 402–8180 (voice) or (301) 435–1908 (TTY). Requests should be made at least seven business days in advance of the meeting. FOR FURTHER INFORMATION CONTACT: Dr. Lori White, NTP Designated Federal Officer, (919) 541–9834, whiteld@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 carcinogenicity studies. The preliminary agenda listing the draft reports and electronic files (PDF) of the draft reports should be posted on the NTP Web site by December 8, 2010. 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 Officer (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 January 26, 2011, from 8:30 a.m. EST to adjournment 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 January 19, 2011, to facilitate access to the NIEHS campus. A photo ID is required to access the NIEHS campus. The NTP is making plans to videocast the meeting through the Internet 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 12, 2011, to enable review by the panel and NTP staff prior to the meeting. Persons submitting written comments should include their name, affiliation, mailing address, phone, e-mail, 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. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 73085 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 8:00 AM until adjournment on January 26, although public comments will be received only during the formal public comment periods indicated on the preliminary agenda. 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 notify Dr. Lori White via online registration at https://ntp.niehs.nih.gov/ go/166, phone, or e-mail (see ADDRESSES above) by January 19, 2011, and if possible, to send a copy of the statement or talking points at that time. Written statements can supplement and 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 Peer Review Panels NTP panels are technical, scientific advisory bodies established on an ‘‘as needed’’ basis to provide independent scientific peer review and advise the NTP on agents of public health concern, new/revised toxicological test methods, or other issues. Previously, a subcommittee of the NTP Board of Scientific Counselors provided peer review of draft NTP Technical Reports. The subcommittee has been discontinued and peer review of the draft reports will now be conducted by peer review panels. 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 Dr. Lori White (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. E:\FR\FM\29NON1.SGM 29NON1 73086 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 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: November 18, 2010. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2010–29945 Filed 11–26–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–4154–PN] Medicare and Medicaid Programs; Renewal of Deeming Authority of the National Committee for Quality Assurance for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations Centers for Medicare & Medicaid Services, HHS. ACTION: Proposed notice. AGENCY: This proposed notice announces the receipt of an application to renew the Medicare Advantage Deeming Authority of the National Committee for Quality Assurance (NCQA) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 4 years. The new term of approval would begin October 19, 2010, and would end October 18, 2014. In addition, this proposed notice announces a 30-day public comment period on the renewal of the application. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 28, 2011. ADDRESSES: In commenting, please refer to file code CMS–4154–PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–4154–PN, P.O. Box 8010, Baltimore, MD 21244–1850. mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:57 Nov 26, 2010 Jkt 223001 Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–4154–PN, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786– 9994 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Caroline L. Baker (410) 786–0116. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: https:// www.regulations.gov. Follow the search instructions on that Web site to view public comments. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951. I. Background Under the Medicare program, eligible beneficiaries may receive covered services through a Medicare Advantage (MA) organization that contracts with the Centers for Medicare & Medicaid Services (CMS). The regulations specifying the Medicare requirements that must be met in order for an Medicare Advantage Organization (MAO) to enter into a contract with CMS are located at 42 CFR part 422. These regulations implement Part C of Title XVIII of the Social Security Act (the Act), which specifies the services that an MAO must provide and the requirements that the organization must meet to be an MA contractor. Other relevant sections of the Act are Parts A and B of Title XVIII and Part A of Title XI of the Act pertaining to the provision of services by Medicare certified providers and suppliers. Generally, for an entity to be an MA organization, the organization must be licensed by the State as a risk bearing organization as set forth in Part 422 of our regulations. To assure compliance with certain Medicare requirements, an MA organization may chose to become accredited by a CMS approved accrediting organization (AO). By doing so, the MA organization may be ‘‘deemed’’ compliant in one or more of 6 requirements set forth in section 1852(e)(4)(B) of the Act. In order for an AO to be able to ‘‘deem’’ an MA plan as compliant with these MA requirements, the AO must prove to CMS that its standards are at least as stringent as Medicare requirements. MA organizations that are licensed as health maintenance organizations (HMOs) or preferred provider organizations (PPOs) and are accredited by an approved accrediting organization may receive, at their request, deemed status for CMS requirements in the following six MA survey areas: (1) Quality Improvement, (2) Antidiscrimination, Access to Services, (3) Confidentiality and Accuracy of Enrollee Records, (4) Information on Advanced Directives, and Provider Participation Rules. (See 42 CFR 422.156(b).) We note that at this E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73085-73086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP): Office of Liaison, Policy, and 
Review; Availability of Draft NTP Technical Reports; Request for 
Comments; Announcement of a Panel Meeting to Peer Review Draft NTP 
Technical Reports

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

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

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

SUMMARY: The NTP announces the availability of draft NTP Technical 
Reports (TRs; available at https://ntp.niehs.nih.gov/go/36051) that will 
be peer-reviewed by an NTP Technical Reports Peer Review Panel at a 
meeting on January 26, 2011. 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). 
Summary minutes from the peer review will be posted on the NTP Web site 
following the meeting.

DATES: The meeting to review the draft NTP TRs will be held on January 
26, 2011. The draft NTP TRs will be available for public comment by 
December 8, 2010. The deadline to submit written comments is January 
12, 2011, and the deadline for pre-registration to attend the meeting 
and/or provide oral comments at the meeting is January 19, 2011.

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 Dr. Lori White, NIEHS, P.O. Box 12233, MD K2-03, 
Research Triangle Park, NC 27709, FAX: (919) 541-0295, or 
whiteld@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 seven business days in advance 
of the meeting.

FOR FURTHER INFORMATION CONTACT: Dr. Lori White, NTP Designated Federal 
Officer, (919) 541-9834, whiteld@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 carcinogenicity studies. The 
preliminary agenda listing the draft reports and electronic files (PDF) 
of the draft reports should be posted on the NTP Web site by December 
8, 2010. 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 Officer (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 January 26, 2011, from 8:30 a.m. EST 
to adjournment 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 January 19, 2011, to facilitate access to the NIEHS campus. A 
photo ID is required to access the NIEHS campus. The NTP is making 
plans to videocast the meeting through the Internet 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 12, 2011, to enable review by the panel and NTP 
staff prior to the meeting. Persons submitting written comments should 
include their name, affiliation, mailing address, phone, e-mail, 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 8:00 AM until adjournment on 
January 26, although public comments will be received only during the 
formal public comment periods indicated on the preliminary agenda. 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 notify Dr. Lori White via 
online registration at https://ntp.niehs.nih.gov/go/166, phone, or e-
mail (see ADDRESSES above) by January 19, 2011, and if possible, to 
send a copy of the statement or talking points at that time. Written 
statements can supplement and 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 Peer Review Panels

    NTP panels are technical, scientific advisory bodies established on 
an ``as needed'' basis to provide independent scientific peer review 
and advise the NTP on agents of public health concern, new/revised 
toxicological test methods, or other issues. Previously, a subcommittee 
of the NTP Board of Scientific Counselors provided peer review of draft 
NTP Technical Reports. The subcommittee has been discontinued and peer 
review of the draft reports will now be conducted by peer review 
panels. 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 Dr. Lori White (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.

[[Page 73086]]

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: November 18, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-29945 Filed 11-26-10; 8:45 am]
BILLING CODE 4140-01-P
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