Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending Office of Management and Budget (OMB) approval of existing reporting requirements on electronic submission of requests for meetings, in person or via teleconference, to discuss with animal drug sponsors studies to be conducted and how to meet the statutory requirements for drug approval under the Federal Food, Drug, and Cosmetic Act. Requests for meetings about new animal drug submissions were previously submitted on paper copy to the Center for Veterinary Medicine (CVM).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending Office of Management and Budget (OMB) approval on the existing reporting requirements relating to how one may submit information electronically to the Center for Veterinary Medicine (CVM), using e-mail.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicaid Statistical Information System (MSIS),'' System No. 09-70-6001, last published at 67 FR 48906 (July 26, 2002). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09- 70-0541. 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. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to establish an accurate, current, and comprehensive database containing standardized enrollment, eligibility, and paid claims of Medicaid beneficiaries to be used for the administration of Medicaid at the Federal level, produce statistical reports, support Medicaid related research, and assist in the detection of fraud and abuse in the Medicare and Medicaid programs. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support a research or evaluation project; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an inadvertent error in the conditions of use of bambermycins free-choice cattle feeds. This action is being taken to improve the accuracy of the animal drug regulations.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR, ``Carrier Medicare Claims Record (CMCR) System,'' System No. 09-70-0501, most recently modified at 67 Federal Register 54428 (August 22, 2002). We propose to change the name of this system to more closely reflect the name of the program used for the processing of Part B claims. We will modify the name to read: ``Medicare Multi-Carrier Claims System (MCS).'' 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. We will modify existing routine use number 5 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs relating to assessing and improving quality of care as well as proper payment of claims. The modified routine use will remain as routine use number 5. We will delete routine use number 8 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 10 and 11, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to properly pay medical insurance benefits to or on behalf of entitled beneficiaries. Information in this system will also be released to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist third party contacts; (4) support providers and suppliers of services dealing through fiscal intermediaries or carriers; (5) support Quality Improvement Organizations (QIO); (6) assist insurance companies and other groups providing protection for their enrollees, insurers and other groups providing protection against medical expenses who are primary payers to Medicare in accordance with 42 U.S.C. Sec. 1395y (b); (7) support an individual or organization for a research, evaluation, or epidemiological project; (8) support litigation involving the Agency related to this SOR; and (9) combat fraud, waste, and abuse in certain Federally-funded health care programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing system of records titled ``Common Working File (CWF),'' System No. 09-70-0526,'' most recently modified at 67 Federal Register (FR) 3210 (January 23, 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. We will delete routine use number 8 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will modify existing routine use number 5 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs relating to assessing and improving quality of care as well as proper payment of claims. The modified routine use will remain as routine use number 5. We will broaden the scope of routine uses number 10 and 11, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to properly pay medical insurance benefits to or on behalf of entitled beneficiaries. Information in this system will also be released to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist another Federal or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) assist third party contacts; (4) assist providers and suppliers of services directly or through fiscal intermediaries or carriers; (5) support Quality Improvement Organizations (QIO) or Quality Review Organizations; (6) assist insurance companies and other groups providing protection for their enrollees, or who are primary payers to Medicare in accordance with 42 United States Code (U.S.C.) 1395y (b); (7) support an individual or organization for research, evaluation, or epidemiological projects; (8) support litigation involving the Agency related to this system of records; and (9) combat fraud, waste, and abuse in certain Federally- funded health care programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

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.

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.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled ``One Program Integrity Data Repository (ODR),'' System No. 09- 70-0568. Section 1893 of the Social Security Act (the Act) established the ``Medicare Integrity Program'' that requires CMS to contract with eligible entities to ``review activities of providers of services or other individuals and entities furnishing items and services for which payment may be made under this title'' by utilizing equipment and software technologies. Likewise, section 1893 of the Act requires CMS to establish the Medicare Medicaid Data Match Program (Medi-Medi) in which data from both the Medicare and Medicaid programs are analyzed together to better detect fraud, waste, and abuse existent in these programs. In order to comply with these requirements and enhance our ability to detect fraud, waste, and abuse in Medicare and Medicaid, CMS is proposing to construct the ODR. CMS maintains numerous systems housing Medicare beneficiary Parts A, B, C, and D entitlement, enrollment, and utilization information. Additionally, CMS maintains data on physicians, providers, employer plans, Medicaid recipients and Medicare secondary payers. There are a large number of data sources, extraction tools, and access mechanisms. Users of the data often experience inconsistent, untimely, or duplicated information. The ODR will be an enterprise resource that will provide an integrated view of the data to all of CMS and its partners providing a single authoritative source of information and providing quality and timely data. The ODR will provide an organized structure for reaching the data through a consistent application of access policies, processes and procedures, common services, governance, and framework. The ODR will integrate and load data from various CMS systems consisting of Medicare Parts A, B, C, and D, Medicaid and Retiree Drug Subsidy entitlement, enrollment and utilization data. The ODR will also contain demographic information on Medicaid beneficiaries, Medicare providers and physicians, and employer plans that are receiving a subsidy from CMS for providing creditable drug coverage to their retirees. It is through the integration of this Medicare data with other data; e.g., historic data, Part A and Part B data, and Medicaid data sets provided by state agencies that CMS fraud, waste, and abuse, quality improvement, research, and other analytic activities are maximized. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 FR 58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70-0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09- 70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525, (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70- 0530 (67 FR 48184 (July 23, 2002)); and the Medicaid data sets provided by participating state agencies. The primary purpose of this system is to establish an enterprise resource that will provide a single source of information for all CMS fraud, waste, and abuse activities. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support Quality Improvement Organizations (QIO); (4) assist other insurers for processing individual insurance claims; (5) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection related to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).'' The guidance explains, using a question and answer format, FDA's current thinking on a number of issues related to the regulation of food allergens, including implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information collection to meet specified requirements for submitting adequate and well-controlled studies to provide substantial evidence of effectiveness for a new animal drug.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Absorbable Hemostatic Device.'' The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). This draft guidance is not final, nor is it being implemented at this time.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the reporting of biological product deviations in manufacturing, and Forms FDA 3486 and 3486A.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Physical Fitness and Sports will hold a meeting. This meeting is open to the public. A description of the Council's functions is included with this notice.

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.

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.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-seventh meeting, at which it will (1) Hear an update on stem cell research; (2) hear presentations on and discuss issues in clinical applications of advancements in genetics, as well as genetics policy and ethics; (3) discuss policy options in organ procurement, transplantation, and allocation; and (4) hear a presentation on and discuss issues in the ethics of health care. Agenda items one through three are continuations of previous Council discussions; the fourth agenda item is a new area of potential inquiry for the Council. Subjects discussed at past Council meetings (although not on the agenda for the November 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan- extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components,'' dated October 2006. The guidance document provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture with advice on reporting to FDA a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials (DHQ documents). The guidance document addresses which DHQ documents are acceptable, and establishes the process for FDA to recognize other DHQ documents in the future. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components'' dated April 2004.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (``MCAC'' or ``the Committee''). MCAC provides guidance and advice to CMS on specific clinical topics under review for Medicare coverage. This meeting concerns reconsideration of the Medicare clinical trial policy. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This proposed rule would require all long term care facilities to be equipped with sprinkler systems. This proposed rule especially requests public comments on the duration of a phase-in period to allow long term care facilities to install such systems.

The Health Resources and Services Administration published a document in the Federal Register of September 22, 2006, regarding a meeting date for the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. The meeting scheduled for November 2-3, 2006, has been cancelled.

The Food and Drug Administration (FDA) is announcing that, under the Paperwork Reduction Act of 1995 (the PRA), the Office of Management and Budget (OMB) has extended the expiration date to May 1, 2007, for the use of the prior version of Form FDA 3500A for ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' (the MedWatch Program).

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the SACATM on November 30, 2006 in Research Triangle Park, North Carolina. The meeting is scheduled from 8:30 a.m. to adjournment (~5 p.m.) and is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activates related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Additional information about SACATM, including the charter, roster, and records of past meetings can be found at https://ntp.niehs.nih.gov/ see ``Advisory Board & Committees'' or directly at https://ntp.niehs.nih.gov/go/167.

The Food and Drug Administration (FDA) is announcing that Safe Foods Corporation has filed a petition proposing that the food additive regulations be amended to expand the conditions for the safe use of cetylpyridinium chloride as an antimicrobial agent in a pre-chiller or post-chiller solution for application to raw poultry carcasses.

The Food and Drug Administration (FDA) is announcing a public hearing on the regulation of certain conventional foods that companies are marketing as ``functional foods.'' The purpose of the hearing is for the agency to share its current regulatory framework and rationale regarding the safety evaluation and labeling of these foods, and to solicit information and comments from interested persons on how FDA should regulate these foods under the agency's existing legal authority.

This notice announces the eleventh meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its eleventh meeting. The meeting will be open to the public. Due to unanticipated issues during preparation for the November meeting of SACHRP, this notice will not meet the 15-day requirement for publication in the Federal Register.

The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1, 2, 4, and 5 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Emergency Use Authorization of Medical Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Evaluation of the Implementation and Impact of Pay-for- Quality Programs.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 14, 2006, page 46486 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Funding opportunities for the Service Area Competition (SAC) funding for the Consolidated Health Center Program were published on grants.gov on August 10, 2006 (HRSA Announcement Numbers 07-008, 07- 111, and 07-112). Appendix D of the SAC program guidance (HRSA-07-008) is amended to remove the opportunity in Pierre, South Dakota, with a project period end date of February 28, 2007. Prior to the end of the project period and subsequent projected competition for that service area, the grant was relinquished to another neighboring organization. This is now part of the service area for another grantee in Pierre, South Dakota. The competitive application for that opportunity will now be due December 15, 2006, under HRSA 07-112.

This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components,'' dated October 2006. The guidance document provides licensed manufacturers of biological products other than blood and blood components with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist the licensed manufacturers of biological products other than blood and blood components in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. This guidance finalizes the draft guidance document of the same title dated August 2001.

This notice announces an administrative hearing to be held on December 4, 2006, at 233 N. Michigan Avenue, Suite 600, the Illinois Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-015B. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by November 2, 2006.