Department of Health and Human Services November 2005 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 283
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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.
Office of the National Coordinator (the Community); Announcement of Meeting
This notice announces the second meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Environmental Assessment; Categorical Exclusions
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).
Request for Nominations for Nonvoting Member Representing Industry Interests on a Public Advisory Committee; Nonprescription Drugs Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for a nonvoting industry representative to serve on the Nonprescription Drugs Advisory Committee.
Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant
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 FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the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.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex.'' This draft guidance document describes a means by which natural rubber latex (latex) condoms with and without spermicidal lubricant containing nonoxynol-9 (N-9) 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 amend the classification regulations for condoms with and without spermicidal lubricant to designate this draft guidance as the special control for latex condoms with and without spermicidal lubricant. This draft guidance is neither final nor is it in effect at this time.
Solicitation of Potential Partners to Participate in Programs of the Office of the President's Council on Physical Fitness and Sports During 2006 50th Anniversary Celebration
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.
Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised compliance policy guide (CPG) Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to finalize the sections pertaining to routine shipments of food that are transshipped through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information.
Announcement of Anticipated Availability of Funds for Family Planning Services Grants
The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Friday, May 6, 2005, announcing the anticipated availability of funds for family planning services grants. This notice contained an error. An eligible State/Population/Area was not listed as available for competition in 2006. This Notice corrects the omission of the State of Nebraska State/Population/Area as competitive in 2006.
Vaccine Information Statements for Influenza Vaccines; Revised Instructions for Use of Vaccine Information Statements
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.
Medical Devices: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff.'' The revised guidance extends the voluntary pilot premarket review program Summary Technical Documentation (STED pilot) until we have received an adequate number of submissions to evaluate the STED pilot. The pilot program is intended for evaluating the utility of an alternative submission procedure.
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates
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.
National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
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 December 12, 2005. 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 activities 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.''
Prospective Grant of Exclusive License: Cleaning Mucus From Endotracheal Tubes
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.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2006
This final rule sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. This final rule is the first update of the home health prospective payment system (HH PPS) rates that uses the revised area labor market Metropolitan Statistical Area designations for calendar year 2006. In implementing the new area labor market designations, we are allowing for a one-year transition period. This transition consists of a blend of 50 percent of the new area labor market designations' wage index and 50 percent of the previous area labor market designations' wage index. In addition, we are revising the fixed dollar loss ratio, which is used in the calculation of outlier payments.
Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
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.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tinnitus Masker Devices.'' The draft guidance describes a means by which tinnitus masker devices 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 amend the classification regulations for the tinnitus masker presently classified into class II (special controls: labeling) to designate a special control for these devices. The draft guidance is neither final, nor is it in effect at this time.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013
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.
Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (135) entitled ``Validation of Analytical Procedures for Type C Medicated Feeds.'' This guidance represents the agency's current thinking on the characteristics that should be considered during the validation of non- microbiological analytical procedures for the analysis of drugs in Type C medicated feeds included as part of original and supplemental new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for Type A medicated articles submitted to FDA. This guidance is the first in a series of three guidances that will discuss assay methods for Type C medicated feeds.
Proposed Collection: Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children OPM-306 Request for Public Comment: 30-Day Notice
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.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Prescription Drug Plan Finder (MPDPF) System, HHS/CMS/CBC, System No. 09-70-0564.'' Under the provisions of Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), CMS has provided the participants of eligibility transactions a query and response solution in a single data center using a three-tier architecture. Enterprise Business Services (EBS), the user interface, will have the responsibility of receiving identifying information on Medicare beneficiaries for processing eligibility requests and enrollment assistance with the Medicare Prescription Drug Benefit Program. These inbound messages will be sent to EBS for processing of the eligibility request and for securing the information from the CMS Community Based Organization/ Customer Service Representative (CBO/CSR) Data Store, and for sending an available plan option response back via the internet. EBS will capture the identifying information and enrollment selection, and transmit it to the selected Medicare Prescription Drug Plan (PDP) or Medicare Advantage Prescription Drug Plan (MAPD). This initiative will streamline and facilitate drug benefit eligibility determination and the enrollment process. The primary purpose of this system is to provide a Web accessible inquiry system that will provide a mechanism to support an individual beneficiary's efforts in performing drug benefit eligibility queries and to enroll them into selected plans. Information in this system will also be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor or consultant; (2) assist PDPs and MAPDs directly or through the Enterprise Business Services; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the Agency related to this system. We have provided background information about the proposed system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that the Aroutine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.
Change of Name; Technical Amendment
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.
Meeting To Discuss Possible Changes to the Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry
The Food and Drug Administration (FDA), in the Department of Health and Human Services, and the Food Safety Inspection Service (FSIS), in the United States Department of Agriculture (USDA), are jointly announcing a public meeting to discuss and solicit information on an approach for providing consistency and predictability with respect to which of the two agencies should have jurisdiction over certain types of food products that contain meat and poultry as ingredients, as well as the opening of a joint agency docket to receive written comments. This notice outlines that approach and solicits comments on it and on the specific questions asked in section II below.
Invitation To Comment on Proposed Data Composites and Potential Performance Areas and Measures for the Child and Family Services Review
This notice is to advise the public of ACF's plan to replace the six national data measures used for the CFSR with six data composites addressing the child welfare domains of maltreatment recurrence, maltreatment in foster care, timeliness of adoptions, timeliness of reunifications, placement stability, and permanency for children. The plan to develop data composites is a response to a recommendation made by a consultant under contract with ACF to study the CFSR process. The recommendation is based on input from a CFSR workgroup convened by the consultant at the end of the first round of CFSRs to assist in identifying areas needing improvement. ACF expects that each data composite will incorporate multiple performance areas and measures relevant to a specific domain. ACF plans to use State performance on the data composites as part of its evaluation of a State's substantial conformity with specific outcomes assessed through the CFSR. National standards will be developed for each of the domains represented by the six data composites. ACF's plan to replace existing measures with data composites is consistent with the final CFSR regulation at 45 CFR 1355.34(b)(4) and (5), which authorizes the Secretary of HHS to add, amend, or suspend any of the statewide data indicators when appropriate, and to adjust the national standards when appropriate. The proposed plan also complies with the requirements of section 1123A of the Social Security Act (the Act) for ACF to assess State child welfare agencies' compliance with titles IV-B and IV-E of the Act as implemented in 45 CFR 1355.31 through 1355.37. We invite the public to comment on the data composites, performance areas, and measures proposed in this announcement.
Proposed Collection; Comment Request; Women's Health Initiative Observational Study
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:
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
