Department of Health and Human Services September 2008 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 273
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
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 PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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.
Product Tracing Systems for Fresh Produce; Public Meetings
The Food and Drug Administration (FDA) is announcing two public meetings regarding product tracing systems for fresh produce. The purpose of the meetings is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for fresh produce and to improve FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce- related outbreaks of foodborne illness. This discussion will help FDA determine what short and long term steps we should take to enhance the current tracing system.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306. Form Number: OPM-306. Forms: Declaration for Federal Employment. 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, and 25 U.S.C. 3201-3211. The IHS is required to compile a list of all authorized positions within the IRS 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 U.S.C. 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: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
Notice of Public Comment on Section 635 [42 U.S.C. 9801]-The 2007 Head Start School Readiness Act, Sub-Section 649(k)(1)(A-D)-“Indian Head Start Study”
The following Notice of Public Comment is in response to section 649(k) Sub-Section (3) of the 2007 Head Start School Readiness Act that requires the Secretary no later than 9 months after the effective date of this Sub-Section, publish in the Federal Register a plan of how the Secretary will carry out section 649 Sub-Section (k) Sub-Paragraph (1) and shall provide a period for public comment.
Office of Community Services
This supplement would enhance the ability for the CAP to find new ways to address training and technical assistance needs. After gathering information from the Community Action Network, the applicant will provide a report to the Office of Community Services (OCS) containing recommendations about creative approaches and strategies for providing technical assistance and training to Community Action Agencies (CAAs). The applicant will compile information gathered thru: Brainstorming sessions with members of the Community Action Network and the Virtual CAP. The report to OCS will include sections on major recommendations and a strategy for implementation. These will be supported by summaries of the ideas presented at the sessions and input compiled by Virtual CAP.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2009
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2009. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2009 are $192.70 for aged enrollees and $224.20 for disabled enrollees. The standard monthly Part B premium rate for 2009 is $96.40, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2008 standard premium rate was also $96.40.) The Part B deductible for 2009 is $135.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.
Medicare Program; Part A Premium for Calendar Year 2009 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2009. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2009 for these individuals will be $443. The reduced premium for certain other individuals as described in this notice will be $244.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2009
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2009 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2009, the inpatient hospital deductible will be $1068. The daily coinsurance amounts for CY 2009 will be: (a) $267 for the 61st through 90th day of hospitalization in a benefit period; (b) $534 for lifetime reserve days; and (c) $133.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Submission for Proposed Collection Comment Request: The Effectiveness of the NIH Curriculum Supplements Programs
In compliance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Science Education, 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: The Effectiveness of the NIH Curriculum Supplements Programs Survey. Information Collection Request: New. Need and Use of Information Collection: The survey will attempt to assess customer demographics and their satisfaction with the NIH curriculum supplements in presenting science in a more engaging and interactive way. The supplements help K-12 educators teach science by featuring the latest NIH research and utilized research-based instructional methods. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or obesity. Web-based simulations, animations and experiments enhance the ``pencil and paper'' activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 6,000 teachers have attended an OSE workshop. Assessing the effectiveness of the NIH curriculum supplements and teacher workshops is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect data from supplement requesters and workshop attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.
Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved ophthalmic balanced salt solutions for irrigation of the eye during surgery and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved ophthalmic balanced salt solutions have been associated with adverse events, some of them leading to permanent loss of visual acuity, because of contamination of the product or other product defects. Ophthalmic balanced salt solutions are new drugs that require approved applications because they are not generally recognized as safe and effective. Two firms have approved applications to market these products. Manufacturers who wish to market ophthalmic balanced salt solutions must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Topical Drug Products Containing Papain; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved topical drug products containing papain and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Topical drug products containing papain are marketed, without approved applications, to debride necrotic tissue and liquefy slough in acute and chronic lesions. Potentially serious adverse events have been reported with topical drug products containing papain. Topical drug products containing papain are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently no firm has an approved application to market a topical drug product containing papain. Manufacturers who wish to market topical drug products containing papain must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Review of NIOSH Draft Current Intelligence Bulletin, “A Strategy for Assigning the New NIOSH Skin Notations for Chemicals”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the NIOSH document ``CIB: A Strategy for Assigning the New NIOSH Skin Notations for Chemicals.'' This draft Current Intelligence Bulletin (CIB) was developed to provide the scientific rationale and framework for a strategy for the assignment of multiple skin notations capable of distinguishing between systemic, localized, and sensitizing health effects of dermal chemical exposures. The strategy has been designed to (1) communicate the current state of knowledge on hazards to workers' health from dermal exposures, (2) address the conceptual shortcomings of the current NIOSH skin notation represented by the symbol [skin], (3) recognize the health risks associated with contact of the skin with chemicals beyond dermal absorption, and (4) increase the transparency of the process for assigning the new NIOSH skin notations. The CIB can be found at: https://www.cdc.gov/niosh/ review/public/109. Public Meeting Time and Date: 9 a.m.-4 p.m. EDT, November 6, 2008. Place: NIOSH, Robert A. Taft Laboratories, Taft Auditorium, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available (the room accommodates approximately 80 people). Due to limited space, notification of intent to attend the meeting must be made to the NIOSH Docket Officer, no later than October 22, 2008. The NIOSH Docket Officer can be reached at (513) 533-8611 or by e-mail at niocindocket@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Non-U.S. Citizens: Because of CDC Security Regulations, any non- U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than October 15, 2008. 1. Name: 2. Gender: 3. Date of Birth: 4. Place of Birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. U.S. Naturalization Number (if a naturalized citizen): 11. U.S. Naturalization Date (if a naturalized citizen): 12. Visitor's Organization: 13. Organization Address: 14. Organization Telephone Number: 15. Visitor's Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. Purpose of the Meeting: To discuss and obtain comments on the draft CIB, ``A Strategy for Assigning the New NIOSH Skin Notations for Chemicals.'' Special emphasis will be placed on discussion of the following issues: 1. Are the proposed classes of skin notations appropriate? 2. Are the proposed criteria for assigning each type of skin notation appropriate? 3. Is the proposed assignment of multiple skin notations useful for protecting workers from dermal hazards? 4. Should the sensitizing effects (SEN) notation apply strictly to allergic contact dermatitis or is it appropriate to assign the SEN notation for other immune-mediate responses, such as respiratory sensitization, airway hyperactivity and mucosal inflammation, associated with dermal exposure to a compound? 5. Does the proposed harmonization scheme found in Appendix G.2 link the new NIOSH skin notations and The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) assignments sufficiently? 6. Should additional information be included within document? If so, what? 7. Do the data cited support the objectives of the document? 8. Are the conclusions appropriate in light of the current understanding of the toxicological data? This document may be found at: https://www.cdc.gov/niosh/review/ public/109/. Written comments may be submitted to the NIOSH Docket Officer, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, OH 45226, telephone (513) 533-8611, facsimile (513) 533- 8230. Comments may also be submitted via e-mail to niocindocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. Comments must be submitted to NIOSH no later than November 7, 2008, and should reference docket number NIOSH-109 in the subject heading. Oral comments made at the public meeting must also be submitted to the docket in writing in order to be considered by the Agency. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Technical Information: Scott Dotson, Industrial Hygienist, NIOSH, CDC, telephone (513) 533-8540, M/S C-32, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
National Vaccine Injury Compensation Program List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 11, 2008 (73 FR 39968). The notice announced the availability of Global Harmonization Task Force documents entitled ``Role of Standards'' and ``Clinical Investigations.'' The notice was published with an incorrect document number. This document corrects that number.
Announcement of Sixth Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the sixth in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020 to be held in Washington, DC. This meeting will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
This notice announces the 22nd meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 18th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 26th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 30th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence.'' This draft guidance document describes FDA's proposed recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence. This draft guidance is not final nor is it in effect at this time.
FDA Regulations; Technical Amendment; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, August 25, 2008 (73 FR 49941). The final rule made technical amendments to several FDA regulations. The document was published with two inaccurate citations in the first paragraph of the Background Section under Supplementary Information. This document corrects that error.
Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document (GFI187) entitled ``Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs.'' This draft guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals. Elsewhere in this same issue of the Federal Register, the Animal and Plant Health Inspection Service (APHIS) is soliciting public comment on any potential implications of activities such as the importation or interstate movement of GE animals on the health of the U.S. livestock population under the authority of the Animal Health Protection Act (AHPA).
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