Department of Health and Human Services November 2005 – Federal Register Recent Federal Regulation Documents

CDC is committed to protecting the health and safety of the American public by preventing the introduction of communicable disease into the United States. Having updated regulations in place is an important measure to ensure swift response to public health threats. CDC proposes to update existing regulations related to preventing the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one State or possession into another.

Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the 2005 White House Conference on Aging (WHCoA) meeting in December 2005 and the final Annotated Agenda for the 2005 WHCoA. The Policy Committee approved this final Annotated Agenda during a meeting held by conference call on November 3, 2005. The Annotated Agenda covers six broad areas that reflect major issues facing older individuals now and for the next 10 years. The 2005 WHCoA will be open to the public. Individuals who wish to attend should call or email the contact person listed below in advance of the meeting and inform her of the day they wish to attend; since space for the public is limited, attendance will be on a first come first-served basis. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person of the type of assistance that is desired.

This Notice provides the status of ATSDR's Superfund-mandated Substance-Specific Applied Research Program (SSARP) which was last updated in a Federal Register notice in 2002 (67 FR 4836). Authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA, also known as the Superfund statute), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604 (i)], this research program was initiated on October 17, 1991. At that time, a list of priority data needs for 38 priority hazardous substances frequently found at waste sites was announced in the Federal Register (56 FR 52178). The list was subsequently revised based on public comments and published in final form on November 16, 1992 (57 FR 54150). The 38 substances, each of which is found on ATSDR's Priority List of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/ dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, chloroethane, chloroform, chromium, cyanide, p,p'-DDT,DDE,DDD, di(2- ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel, polychlorinated biphenyl compounds (PCBs), polycyclic aromatic hydrocarbons (PAHsincludes 15 substances), selenium, tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and zinc. On July 30, 1997, priority data needs for 12 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (62 FR 40820). The 12 substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are chlordane, 1,2-dibromo-3-chloropropane, di-n-butyl phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan (alpha-, beta-, and endosulfan sulfate), heptachlor (includes heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha- , beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene. More recently, priority data needs for 10 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (68 FR 22704). The ten substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins, 1,2-dibromoethane, 1,2-dichloroethane, 1,1-dichloroethene, ethylbenzene, pentachlorophenol, 1,1,2,2-tetrachloroethane, and total xylenes. Currently, the priority data needs for acrolein and barium are being identified and will be reported in a future Federal Register notice. To date, 270 priority data needs have been identified for the 60 hazardous substances, and 86 priority data needs have been filled (Table 1). ATSDR fills these research needs through U.S. Environmental Protection Agency (EPA) regulatory mechanisms (test rules), private- sector voluntarism, and the direct use of CERCLA funds. Additional priority data needs are being addressed through collaboration with the National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health Effects Research Program, and other Agency programs. Priority data needs documents describing ATSDR's rationale for prioritizing research needs for each substance are available. See ADDRESSES section of this Notice. This Notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this Notice by indicating their interest through submission of a letter of intent to ATSDR (see ADDRESSES section of this Notice). A Tri-Agency Superfund Applied Research Committee (TASARC) composed of scientists from ATSDR, National Institute of Environmental Health Sciences (NIEHS)/NTP, and the EPA, will review all proposed voluntary research studies.

This Federal Register notice seeks the comments of interested parties on draft compliance guidance developed by the Office of Inspector General (OIG) for recipients of extramural research awards from the National Institutes of Health (NIH) and other agencies of the U.S. Public Health Service (PHS). Through this notice, OIG is setting forth its general views on the value and fundamental principles of compliance programs for colleges and universities and other recipients of PHS awards for biomedical and behavioral research and the specific elements that these award recipients should consider when developing and implementing an effective compliance program.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2) notice is hereby given that the President's Committee for People with Intellectual Disabilities will hold its third quarterly meeting by telephone conference call to discuss items related to people with intellectual disabilities. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, assistive listening devices, or materials in alternative format, should inform Ericka Alston, Executive Assistant, President's Committee for People with Intellectual Disabilities, Telephone202-619-0634, Fax202-205- 9519, E-mail: ealston@acf.hhs.gov, no later than November 30, 2005. Efforts will be made to meet special requests received after that date, but availability of special needs accommodations to respond to these requests cannot be guaranteed. This notice is being published less than 15 days prior to the conference call due to scheduling problems. Agenda: The Committee plans to discuss the Social Security Administration's proposed amendments to the Ticket to Work and Self- Sufficiency Program, the Employer Work Incentive Act for Individuals with Severe Disabilities and an update on the Medicaid Commission. The Honorable Martin H. Gerry, Deputy Commissioner, Disability and Income Security Programs, Social Security Administration, and John D. Kemp, attorney and advocate for people with disabilities, will be guest speakers.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Phoenix Scientific, Inc., to IVX Animal Health, Inc. In order to improve the accuracy of the regulations, erroneous entries for Phoenix Pharmaceutical, Inc., are also being removed at this time.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health. The supplemental NADA provides for revised labeling for the veterinary prescription use of injectable boldenone solution in horses.

The Food and Drug Administration (FDA) is proposing to amend its food labeling regulations for the expanded use of the nutrient content claim ``lean'' on the labels of foods categorized as ``mixed dishes not measurable with a cup'' that meet certain criteria for total fat, saturated fat, and cholesterol content. This proposal responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). This action also is being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.

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 focus groups as used by FDA to gauge public opinion. Policymakers can use focus group results to test and refine their ideas so they can conduct further research, as well as, adopt new policies and to allocate or redirect significant resources to support these policies.

This final rule adopts as final, and makes amendments to, the interim final rule published on August 15, 2003. That interim final rule implemented the statutory requirement that claims for reimbursement under the Medicare Program be submitted electronically as of October 16, 2003, except where waived. These regulations identify those circumstances for which mandatory submission of electronic claims to the Medicare Program is waived.

In accordance with the requirements of the Privacy Act of 1974, we are proposing a new SOR titled, ``National Disaster Medical System (NDMS) Claims Processing System (CPS), No. 09-70-0572.'' CMS is responsible for establishing and administering a payment mechanism for definitive medical care provided under the National Disaster Medical System (NDMS) in accordance with section 2811 of the Public Health Service Act, 42 United States Code (U.S.C.) 300hh-11, a Memorandum of Agreement (MOA) entered into by the NDMS Partnersthe Departments of Homeland Security, Health and Human Services, Defense, and Veteran's Affairs, and an Inter-Agency Agreement between CMS and the Federal Emergency Management Agency (FEMA). Reimbursement to NDMS-participating hospitals (and practitioners furnishing medical services to NDMS- authorized patients during inpatient stays in those hospitals) for definitive medical care will be administered through the NDMS-CPS. The new system will collect data relating to individuals who receive NDMS- authorized medical treatment or services in NDMS hospitals for illness or injury resulting from a specified public health emergency or non- deferrable medical treatment or services to maintain health when such are temporarily not available as a result of the public health emergency. Data on individuals will be submitted by the Departments of Defense and Veteran's Affairs, staffed Federal Coordinating Centers activated by the NDMS, NDMS hospitals, and practitioners within NDMS hospitals that furnish medical treatment or services to NDMS patients. The primary purpose of the system is to justify and document payments for inpatient hospital and related practitioner services provided in connection to the NDMS. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by CMS and the NDMS Partners, contractors (including the NDMS claims contractor), and consultants contracted by the Agency; (2) support another Federal (including the NDMS Partners) agency of a state government, an agency established by state law, or its fiscal agent; (3) assist NDMS-participating hospitals (and practitioners within those hospitals) who have furnished services to individuals evacuated and placed by the NDMS; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (6) support constituent requests made to a congressional representative; (7) support litigation involving the Agency, and (8) combat fraud and abuse in certain Federal 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 proposed 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 its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging (WHCoA) will have a conference call to finalize the resolutions and other items related to the 2005 WHCoA. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.

This notice extends the comment period for a proposed rule published in the Federal Register on September 23, 2005 (70 FR 55990) that would recommend the adoption of a set of standards to facilitate the electronic exchange of clinical and administrative data to further improve the claims adjudication process when additional documentation is required. Due to the very technical nature of this rule, the industry is asking for additional time to conduct a more comprehensive and thorough review in order to provide comments to the Standards Development Organizations as well as to CMS. The comment period is extended for 60 days.

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 proposed collection of information associated with the guidance document entitled ``Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.'' Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the Office of Management and Budget (OMB's) approval of this collection of information (OMB control number 0910-0571). Since this was an emergency approval that expires on January 1, 2006, FDA is following the normal PRA clearance procedures by issuing this notice.

OIG periodically develops and issues guidance, including Special Advisory Bulletins, to alert and inform the health care industry about potential problems or areas of special interest. This Federal Register notice sets forth the recently issued OIG Special Advisory Bulletin addressing patient assistance programs for Medicare Part D enrollees.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-second meeting, at which, among other things, it will discuss ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. 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 providing notice that it has approved a supplemental new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for oral use of an ivermectin and praziquantel paste as an over-the-counter product for the treatment and control of various parasitic conditions of horses. This supplemental NADA reduces the minimum age for administration from 5 months to 2 months of age.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of florfenicol by veterinary feed directive in catfish feed for the control of mortality due to enteric septicemia of catfish.

This interim final rule with comment period provides clarification and solicits comments on the relationship between drugs supplied under the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals and the calculation of Average Sales Price (ASP). (For purposes of this interim final rule, the term ``drug'' refers to drugs and biologicals.) This interim final rule with comment period also will exclude units of drugs supplied under the CAP from ASP calculations for a period of up to 3 years, at which time the policy will be re-evaluated. In addition, this rule revises the definition of unit to reflect the exclusion of units of CAP drugs administered to beneficiaries by participating CAP physicians.

The Food and Drug Administration (FDA) is providing notice of an Implementation Plan on the sharing of confidential information between the European Commission's Health and Consumer Protection Directorate General and the United States Food and Drug Administration of the Department of Health and Human Services. The purpose is for both participants to cooperate to facilitate the sharing of documents and/or information related to food safety.

Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging (WHCoA) will have a conference call to finalize the resolutions and other items related to the 2005 WHCoA. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.

On February 9, 2005, the Office of Community Services, Administration for Children and Families, U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Demonstration Program. The announcement appeared in Volume 70, pages 6879-6888 of the Federal Register. This document announces a change in the application receipt requirements. To be considered timely for all application due dates, applications now must be received at the OCS Operations Center no later than the due dates. The Program Announcement for Assets for Independence Demonstration Program is a standing announcement. It is effective until canceled or changed by the Office of Community Services (OCS). Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applications submitted by any of three due dates: March 15, June 15, and November 1. (If a date falls on a weekend, the due date will be the following Monday.) For example, starting in mid-March annually, OCS will review all applications submitted November 2 through March 15. Starting in early June, OCS will review all applications submitted March 16 through June 15. And, starting in early November, OCS will review all applications submitted June 16 through November 1. Unsuccessful applicants may submit a new application in any succeeding application period. (1) Under Section IV.3. Submission Dates and Times Please Delete the following: Explanation of Due Dates The closing time and date for receipt of applications is referenced above. Mailed applications postmarked after the closing date will be classified as late. Deadline: Mailed applications shall be considered as meeting an announced deadline if they are either received on or before the deadline date or sent on or before the deadline date and received by ACF in time for the independent review referenced in Section IV.6. Applicants must ensure that a legibly dated U.S. Postal Service postmark or a legibly dated, machine produced postmark of a commercial service is affixed to the envelope/package containing the application(s). To be acceptable of proof of timely mailing, a postmark from a commercial mail service must include the logo/emblem of the commercial mail service company from the applicant. Private Metered postmarks shall not be acceptable as proof of timely mailing. (Applicants are cautioned that express/overnight mail services do not always deliver as agreed.) Please Replace the deleted paragraphs under Section IV.3. Submission Dates and Times with the following: Explanation of Due Dates The closing time and date for receipt of applications is referenced above. Applications received after 4:30 p.m., eastern time, on the closing date will be classified as late and will not be considered in the current competition. Applicants are responsible for ensuring that applications are mailed or submitted electronically well in advance of the application due date. (Applicants are cautioned that express/overnight mail services do not always deliver as agreed.) All information in this Notice of amendment is accurate and replaces information specified in the February 9, 2005 Notice. Announcement Availability: The Assets for Independence Demonstration Program announcement and all application materials are available at https://www.Grants.gov. Standard forms and certifications may also be found at https://www.acf.hhs.gov/programs/ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/ assetbuilding provides much information about the Assets for Independence Demonstration Program and the application process. The page includes links to all required forms as well as to a guidebook for developing an AFI Project and applying for an AFI grant.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to Provide Input on two proposed documents: ``Recommendations for Applying the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses in Medical Diagnosis, Research and Population Surveillance, Worker Health Monitoring, Government Program Eligibility, and Compensation Settings,'' and ``Ethical Considerations for B Readers.'' The National Institute for Occupational Safety and Health (NIOSH), acting on behalf of the Secretary of Health and Human Services (HHS), is responsible for prescribing the manner in which radiographs are read and classified for the chest x-ray program available to coal miners under the Federal Mine Safety and Health Act, 30 U.S.C. 843; 42 CFR part 37. In carrying out this responsibility, NIOSH issues B Reader certifications to physicians who demonstrate proficiency in the classification of chest radiographs for the pneumoconioses using the International Labour Office (ILO) Classification System. NIOSH uses these B Readers in its Coal Workers Health Surveillance Program. B Readers are also employed in a variety of other clinical, research and compensation settings. NIOSH is using the issuance of the new International Labour Office (ILO) Classification of Radiographs as an opportunity to expand its Web site on the B Reader Program and use of the ILO system. NIOSH-certified B Readers use the internationally- recognized ILO system to classify chest radiographs for the presence and severity of pulmonary parenchymal and pleural changes potentially caused by exposure to dusts such as asbestos, silica, and coal mine dust. The revised program Web site provides more information about radiographic reading and the ILO system including recommendations or ``best practices'' for use of the ILO system in different settings. We are specifically seeking public comment for the draft Document: ``Recommendations for Applying the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses in Medical Diagnosis, Research and Population Surveillance, Worker Health Monitoring, Government Program Eligibility, and Compensation Settings.'' This document can be found at https://www.cdc.gov/ niosh/ topics/ chestradiography/ recommendations.html. At this same time, NIOSH is also seeking comment on its proposed [l x dquo]Ethical Considerations for B Readers'' which can be found at this same Web site. In a recent decision in the In Re Silica Products Litigation, 2005 WL 1593936 (S.D. Tex June 30, 2005), Federal District Court Judge Janis Jack raised questions regarding the ethical conduct of certain physicians, some of whom were B Readers, in reading x-rays in litigation. NIOSH is proposing ``Ethical Considerations for B Readers'' which includes a code of ethics modeled after those of the American College of Radiology and the American Medical Association. We welcome comments on this proposed code of ethics. Please review and submit your comments on either or both of these documents to CWHSP@cdc.gov. If you would prefer to have a hard copy rather than electronic, please contact NIOSH at this same e-mail address, and we will be happy to fax or mail copies of the documents to you. The documents will remain available for comment until January 17, 2006. After that date, NIOSH will consider all the comments submitted and make appropriate revisions to the document before posting a final version on its Web site.

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 requirements for filing objections and requests for a hearing on a regulation or order.

The CERHR announces the availability of the DEHP update expert panel report on November 21, 2005 from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). The expert panel report is an updated evaluation of the reproductive and developmental toxicity of DEHP conducted by an 11-member expert panel composed of scientists from the Federal government, universities, and private organizations. The expert panel met in public on October 10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to DEHP is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. The CERHR invites the submission of public comments on this expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR previously solicited public comment on the draft version of this expert panel report (70 FR 43870-43871, July 29, 2005).

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 the reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to take the following actions: Petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; file a petition for an administrative reconsideration or an administrative stay of action; and request an advisory opinion from the Commissioner.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Program Funding'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending its regulation on environmental impact considerations to expand existing categorical exclusions to include approvals of humanitarian device exemptions (HDEs) and establishment of special controls as categories of actions that do not individually or cumulatively have a significant effect on the human environment and for which neither an environmental assessment (EA) nor an environmental impact statement (EIS) is required. FDA is taking this action in accordance with the National Environmental Policy Act (NEPA).

The Food and Drug Administration (FDA) is proposing to amend the classification regulations for condoms and condoms with spermicidal lubricant containing nonoxynol-9 (condoms with spermicidal lubricant) to designate a special control for natural rubber latex (latex) condoms with and without spermicidal lubricant. FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the agency believes will help provide a reasonable assurance of the safety and effectiveness of the devices. Elsewhere in this issue of the Federal Register, FDA is announcing a notice of availability of the draft special controls guidance document for public comment.

The Office of the President's Council on Physical Fitness and Sports (PCPFS) is soliciting proposals for the establishment of partnerships with non-Federal public and private sector organizations, with the goal of developing, implementing, promoting, and evaluating physical activity, fitness, and sports participation activities and initiatives. These partnerships are particularly targeted at calendar year 2006, which marks the 50th anniversary of the PCPFS. This Partnership Initiative is not a grant or contract award program. It is intended to provide opportunities for the Office of the PCPFS and non- Federal public and private sector organizations to work together both to enhance and integrate existing partnerships and also to create new physical activity, fitness, and sports initiatives at the national, state, and local levels to promote better health and fitness for all Americans in a synergistic and collaborative environment. These partnerships will be voluntary, and each partner will be responsible for supporting its own activities. Potential co-sponsors must have a demonstrated interest in physical activity, fitness, and/or sports activities and be willing to participate substantively in the co- sponsored activity.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On July 28, 2005, CDC published a notice in the Federal Register (70 FR 43694) seeking public comments on proposed new vaccine information materials for trivalent influenza vaccines and hepatitis A vaccines. The 60 day comment period ended on September 26, 2005. Following review of the comments submitted and consultation as required under the law, CDC has finalized the influenza vaccine information materials. The final influenza materials, and revised instructions for their use and for use of materials for other covered vaccines, are contained in this notice. The final hepatitis A vaccine information materials will be published later.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the final rule with comment period describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. This final rule with comment period also changes the requirement for physician oversight of mid-level practitioners in critical access hospitals (CAHs). In this final rule with comment period, we also are responding to public comments received on the November 15, 2004, final rule with comment period pertaining to the ambulatory payment classification (APC) group assignment of Healthcare Common Procedure Coding System (HCPCS) codes identified in Addendum B of that rule with the new interim (NI) comment indicator. These changes are applicable to services furnished on or after January 1, 2006.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E- 061-2004/0, ``Mucus Shaving Apparatus for Endotracheal Tubes'' (Patent Application Ser. No. 10/773,570 filed February 5, 2004), and E-061- 2004/1, ``Mucus Shaving Apparatus for Endotracheal Tubes with Bacteriocidal Properties'' (International Patent Application PCT/ US2005/003395 filed February 5, 2005), to C.R. Bard, Inc., a New Jersey corporation having its headquarters in Murray Hill, New Jersey and a division, Bard Medical Division, having offices in Covington, GA. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in the field of cleaning mucus deposits from endotracheal tubes.

The Food and Drug Administration (FDA) is proposing to amend the classification regulations of tinnitus masker devices in order to specify a special control for the device. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 013'' (Recognition List Number: 013), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was published in the August 3, 2005, Federal Register (70 51826) and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. PROPOSED COLLECTION: Title: 0917-0028, ``Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children OPM-306''. Type of Information Collection Request: Extention of a currently approved collection which expires November 30, 2005. Type of Information Collection Request: Extension of a currently approved collection which expires November 30, 2005. Form Number: OF- 306 Addendum to Declaration for Federal Employment (OF 306) Indian Health Service Child Care & Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of collection information required by section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law 101-630, 104 Stat. 4544, 25 U.S.C. 3201-3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. Section 3207(b) of the Indian Child Protection and Family Violence Prevention Act was amended by Section 814 of S. 3031, the Native American Laws Technical Corrections Act of 2000, which requires that the regulations prescribing the minimum standards of character ensure that none of the individuals appointed to positions involving regular contact with, or control over Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution, crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal government and every facility operated by the Federal government (or operated under contract with the Federal government), that hires (or contracts for hire) individuals involved with children under the age of 18 or child care services to assure that all existing and newly-hired employees undergo a criminal history background check. The background is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal government, or for a facility or program operated by (or through contract with) the Federal government, in positions involved with the provision to children under the age of 18 or child care services, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individual and households. Type of Respondents: Individuals. Table 1 below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.

The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name for AOAC INTERNATIONAL. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414 Exp: 04/06. Need for Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: On occasion. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows: