The Federal Register

National Center for Environmental Health/Agency for Toxic Substances and Disease Registry

Thu, Dec 7 2006 11:00:00 GMT

The Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR): Teleconference.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), CDC, NCEH/ATSDR announces the following subcommittee meeting:

Time and Date: 8:30 a.m.10:30 p.m. Eastern Standard Time, December 19, 2006.

Place: The teleconference will originate at NCEH/ATSDR in Atlanta, Georgia. To participate, dial 877/3156535 and enter conference code 383520.

Purpose: Under the charge of the BSC, NCEH/ATSDR, the PPRS will provide the BSC, NCEH/ATSDR with advice and recommendations on NCEH/ ATSDR program peer review. They will serve the function of organizing, facilitating, and providing a longterm perspective to the conduct of NCEH/ATSDR program peer review.

Matters to be Discussed: An overview of PPRS activities; a

Privacy Act of 1974; Report of a Modified or Altered System of Records

Thu, Dec 7 2006 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to modify or alter existing system of records titled ``Medicare Exclusion Database'' (MED), System No. 09700534,'' established at 67 Federal Register 8810 (February 26, 2002). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1.

Published routine use number 2 and 3 will be combined as one because both are written to complete the same or similar purpose. Disclosures allowed by published routine uses numbers 2, and 3 will be covered by a new routine use numbered 2 to permit release of information to ``another Federal and/or State agency, agency of a

Privacy Act of 1974; Deletion of System of Records

Thu, Dec 7 2006 11:00:00 GMT

CMS proposes to delete 10 systems of records from its inventory subject to the Privacy Act of 1974 (Title 5 United States Code Sec. 552a). CMS is reorganizing its databases because of the amount of information it collects to administer the Medicare program. Retention and destruction of the data contained in these systems will follow the schedules listed in the system notice.

Proposed Information Collection Activity: Comment Request

Thu, Dec 7 2006 11:00:00 GMT

Proposed Projects

Title: Compassion Capital Fund EvaluationIndicators of Organizational Capacity Among Targeted Capacity Building Program Grantees.

OMB No.: New Collection.

Description: This proposed information collection activity is for a study that is one component of the evaluation of the Compassion Capital Fund (CCF) program. The information collection will be through mailed surveys to be completed by selected faithbased and community organizations that received Targeted Capacity Building grants under the CCF program.

The overall evaluation includes multiple components that will examine indicators, outcomes and effectiveness of the CCF in meeting its objective of improving the capacity of faithbased and community organizations. This component of the evaluation will involve approximately 250 faithbased and community organizations. Information will be sought from these organizations to assess change and improvement in various areas of organizational capacity resulting from re

Use of Ozone-Depleting Substances; Removal of Essential Use Designations

Thu, Dec 7 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulation on the use of ozonedepleting substances (ODSs) in pressurized containers to remove the essential use designations for beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide used in oral pressurized metereddose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDAregulated product that releases an ODS is essential. None of these products is currently being marketed, which provides grounds for removing their essential use designation. We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section in this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If [[Page 70871]]
significant adverse comments are received, we will with

Color Additive Certification; Increase in Fees for Certification Services

Thu, Dec 7 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is amending an interim final rule (IFR) that was published in the Federal Register of March 29, 2005 (70 FR 15755). The IFR amended the color additive regulations by increasing the fees for certification services. The IFR was published with one typographical error regarding fees for repacks of certified color additives and color additive mixtures. FDA also inadvertently omitted the color certification fee study referenced in the IFR from the docket at the time of publication. This document corrects the typographical error in the fees for repacks of certified color additives and color additive mixtures, announces the availability of the referenced color certification fee study, and provides for additional time to submit comments.

Use of Ozone-Depleting Substances; Removal of Essential Use Designations; Companion Document to Direct Final Rule

Thu, Dec 7 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, that is intended to amend our regulation on the use of ozonedepleting substances (ODSs) in pressurized containers to remove the essential use designations for beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide used in oral pressurized metereddose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDAregulated product that releases an ODS is essential. None of these products is currently being marketed, which provides grounds for removing their essential use designation.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Dec 7 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Withdrawal of Federal Register Notice

Thu, Dec 7 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the withdrawal of a 60day notice that published in the Federal Register of October 31, 2006 (71 FR 63765). The document published in error.

Findings of Research Misconduct

Thu, Dec 7 2006 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Jennifer Blaisdell, University of Pennsylvania and Retinal Consultants of Arizona, Ltd.: Based on the report of an investigation conducted by the University of Pennsylvania (UP) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Ms. Jennifer Blaisdell, former Clinical Coordinator for Retinal Consultants of Arizona, Ltd. (RCA), committed research misconduct in a study sponsored by two cooperative agreements funded by the National Eye Institute (NEI), National Institutes of Health (NIH): U10 EY012261, ``Agerelated Macular Degeneration Prevention Trial,'' Dr. Stuart Fine, Principal Investigator (P.I.), and U10 EY012279, ``Coordinating Center for AMD, Complications of Age Related Macular Degeneration Prevention Trial'' (CAPT), Dr. Maureen McGuire, P.I.

Specifically, PHS found tha

National Cancer Institute; Notice of Closed Meeting

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2) notice
[[Page 70974]]

is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The purpose of this meeting is to evaluate proposals for support through the RAID program by making available to the research community, on a competitive basis, NCI new agent development contract resources for the preclinical development of drugs and biologics. The outcome of the evaluation will be a decision whether NCI should support the request and make available contract resources for support through the RAID program to the research community, NCI new agent development for the preclinical development of drugs and biologics. The research proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal info

National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Demonstration and Education Research Grants.

Date: December 15, 2006.

Time: 9 a.m. to 1 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: Patricia

National Human Genome Research Institute; Notice of Closed Meetings

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

Name of Committee: Center for Inherited Disease Research Access Committee Group A.

Date: January 5, 2007.

Time: 8:30 a.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015.

Contact Person: Jerry Roberts, PhD, Scientific Review Administrator, Scientific

National Institute of Mental Health; Notice of Meeting

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Mental Health Council.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Advis

National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclose of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Deafness and Other Communication Disorders Special Emphasis Panel, P30 Grant Review. [[Page 70976]]

Date: January 25, 2007.

Time: 8 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Stanley

National Institute on Drug Abuse; Notice of Closed Meeting

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDA. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Board of Scientific Counselors, NIDA.

Date: January 11, 2007.

Time: 8:30 a.m. to 6 p.m.

Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns

National Library of Medicine; Notice of Meetings

Thu, Dec 7 2006 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meetings of the Board of Regents of the National Library of Medicine.

The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Name of Committ