Department of Health and Human Services October 2008 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 332
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient
Document Number: E8-25091
Type: Notice
Date: 2008-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants in the Cities Readiness Initiative and Their Household Members; Availability
Document Number: E8-25062
Type: Notice
Date: 2008-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, HHS. The Authorization contains, among other things, conditions on the emergency use of doxycycline hyclate tablet emergency kits. The Authorization follows the determination by the Secretary of the Department of Homeland Security that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of such determination, Secretary of Health and Human Services Michael O. Leavitt (the Secretary) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a). The Authorization, which includes an explanation of the reasons for its issuance, is reprinted in this Notice.
National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP); Request for Information (NOT-ES-09-001): Ongoing Research and Research Needs for Biological Effects of Exposure to Bisphenol A (BPA)
Document Number: E8-25053
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services
The NIEHS Division of Extramural Research and Training (DERT) and the NTP are seeking input on a number of key research areas that have been identified in recent evaluations of bisphenol A (BPA). Information provided will be used to help focus future research and testing activities on BPA. This Request for Information (RFI) is for planning purposes only and should not be construed as a funding opportunity or grant program. The NIEHS and NTP welcome input from the lay public, environmental health researchers, healthcare professionals, educators, policy makers, industry, and others with an interest in BPA.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: E8-25036
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Amendment of Notice
Document Number: E8-25034
Type: Notice
Date: 2008-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the public meeting notice entitled ``Preparation for ICH meetings in Brussels, Belgium.'' This meeting was announced in the Federal Register of September 16, 2008 (73 FR 53428). The amendment is being made to reflect changes in the Location portion of the document. There are no other changes.
National Institute of Mental Health; Notice of Meeting
Document Number: E8-25024
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-25023
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-25022
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
Document Number: E8-24991
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services
This notice announces the meeting date for the 25th 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). Meeting Date: November 12, 2008, from 8:30 a.m. to 2:45 p.m. (Eastern)
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: E8-24950
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-24948
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Evaluation of Risk Factors Associated With Viral Infections in Chinese Donors: a. Risk Factors Associated With HIV; b. Risk Factors Associated With Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV).
Document Number: E8-24947
Type: Notice
Date: 2008-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) 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 was previously published in the Federal Register on July 31, 2008, pages 44751-44753 and allowed 60 days for public comment. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a current valid OMB control number. Proposed Collection: Title: Evaluation of Risk Factors Associated with Viral Infections in Chinese Donors: a. Risk factors associated with Human Immunodeficiency Virus (HIV), b. Risk factors associated with Hepatitis B virus (HBV) and Hepatitis C virus (HCV). This collection will cover two protocols as stated in the title. The first protocol will aim to study risk factors associated with HIV in Chinese donors and the second protocol will study risk factors related to HBV and HCV in Chinese donors. Type of Information Collection Request: NEW. Need and Use of Information Collection: Understanding the risk factors associated with HIV, HBV and HCV infections in donors is essential for developing donor behavioral screening policies. Injection drug use, sexual transmissions, transfusion history, and medical injections are thought to be major routes of transmission in China but their relative importance in blood donors is unknown. In the U.S., risk factors have been better characterized, but questions still remain. Risk factors cannot be identified in 33% and 40% of persons with acute hepatitis B and C respectively, and risk factors may differ between the U.S. and China. This study will improve our understanding of potential transfusion transmitted viral risk factors that cannot be optimally studied in the U.S. because of their low prevalence. For example, we may be able to assess whether treatments commonly used in China, such as acupuncture and medical injections, are important routes of HBV and HCV transmission. The primary objectives of the proposed study are to assess: The primary risk factors associated with HIV, HBV and HCV. The relative importance of injection drug use, heterosexual transmission, family history, transfusion history, history of previous whole blood or plasma donation, male to male sex, medical injections, acupuncture, and tattoos as routes of transmission for HIV, HBV and HCV. Other important routes of transmission for these viruses such as sex with an injection drug user, snorting drugs, living with someone who has HBV and HCV, living with someone who injects drugs, sharing a toothbrush or a razor, having been in jail, occupational history, having surgery, etc. It is proposed to conduct a large, multi blood center case-control study to meet the study objectives. Cases for the HIV protocol will be donors with confirmed anti-HIV antibody reactivity. Blood centers will select a random group of donors with negative infectious disease test results as Controls for this study. Controls will be enrolled with a 2:1 ratio to Cases and will be matched to the Cases by blood center and donation month. Blood centers will contact potential Controls by phone and/or mail, inviting them to come back to participate in this study. Cases and Controls will be consented and interviewed using the same Risk Factor Questionnaire (RFQ) by Chinese-CDC (C-CDC) or blood center staff, either at the local C-CDC or blood center. The second protocol assessing risk factors related to HBV and HCV will have three groups of donors: ``HBV Group'': HBV (HBsAg) positive donors either from prescreening (rapid testing) or routine screening testing. Confirmatory testing for HBV will be done for these donors. ``HCV Group'': HCV (anti-HCV) positive donors from routine screening testing (blood centers do not do prescreening rapid testing for anti- HCV). Confirmatory testing for HCV will be done for these donors. The third group will be a ``Control Group'' including donors with negative results for all prescreening and routine screening tests. No additional testing is done for these donors. On a monthly basis, the blood centers will use the confirmatory testing results for HBV and HCV respectively, to generate a list of cases. For that same month, the blood center will generate a list of controls (randomly selected and matched by blood center and month of donation). The same control group will be used for HBV and HCV cases. Donors in all three groups will be mailed a Risk Factor Survey study packet. The packet will include a study information sheet (discussing the purpose and nature of this study), an informed consent document explaining the voluntary nature, the benefits and risks of this study, a RFQ, a small monetary reward for taking the survey and an envelope with paid postage for the donor to mail their completed questionnaire back to the blood center. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 3,920; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.33; and Estimated Total Annual Burden Hours Requested: 1,293.5. The annualized cost to respondents is estimated at: $1,940.25 (based on $1.50 per hour). According to China's National Bureau of Statistics in 2006, the average annual wage in China is 21,001 Chinese Yuan (or $2,958 U.S. dollars based on current exchange rate of 1 U.S. dollar = 7.1). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-24812
Type: Notice
Date: 2008-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Guidance for Industry on Tropical Disease Priority Review Vouchers; Availability
Document Number: E8-24932
Type: Notice
Date: 2008-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of section 1102 of the Food and Drug Administration Amendments Act (FDAAA), which adds a new section 524 to the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of section 524.
National Vaccine Advisory Committee
Document Number: E8-24893
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States, and recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
Meeting of the National Biodefense Science Board
Document Number: E8-24843
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-24833
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: E8-24832
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-24830
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: E8-24829
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
President's Committee for People With Intellectual Disabilities; Notice of Meeting
Document Number: E8-24798
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medical Examination of Aliens-Revisions to Medical Screening Process
Document Number: E8-24797
Type: Rule
Date: 2008-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), published an Interim Final Rule in the Federal Register on October 6, 2008 (73 FR 58047), updating regulations that govern medical examinations that aliens must undergo before they may be admitted to the United States. This document corrects an omission contained in the rule.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E8-24796
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Final Rules for Group Health Plans and Health Insurance Issuers Under the Newborns' and Mothers' Health Protection Act
Document Number: E8-24666
Type: Rule
Date: 2008-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Employee Benefits Security Administration, Department of Labor, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final rules for group health plans and health insurance issuers concerning hospital lengths of stay for mothers and newborns following childbirth, pursuant to the Newborns' and Mothers' Health Protection Act of 1996 and the Taxpayer Relief Act of 1997.
National Eye Institute; Notice of Closed Meetings
Document Number: E8-24055
Type: Notice
Date: 2008-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Declaration Under the Public Readiness and Emergency Preparedness Act
Document Number: E8-24737
Type: Notice
Date: 2008-10-17
Agency: Office of the Secretary, Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for smallpox countermeasures based on a credible risk that the threat of exposure to variola virus, the causative agent of smallpox or other orthopoxvirus and the resulting disease constitutes a public health emergency.
Pandemic Influenza Vaccine-Amendment
Document Number: E8-24736
Type: Notice
Date: 2008-10-17
Agency: Office of the Secretary, Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza.
Declaration Under the Public Readiness and Emergency Preparedness Act
Document Number: E8-24735
Type: Notice
Date: 2008-10-17
Agency: Office of the Secretary, Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for Acute Radiation Syndrome countermeasures based on a credible risk that the threat of high dose radiation exposure following the deliberate detonation of a nuclear device, unintentional nuclear release, or other radiological events and the Acute Radiation Syndrome resulting from such exposures constitutes a public health emergency.
Declaration Under the Public Readiness and Emergency Preparedness Act
Document Number: E8-24734
Type: Notice
Date: 2008-10-17
Agency: Office of the Secretary, Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for Botulism countermeasures based on a credible risk that the threat of exposure to botulinum toxin(s) and the resulting disease(s) from a manmade or natural source constitutes a public health emergency.
Declaration Under the Public Readiness and Emergency Preparedness Act
Document Number: E8-24733
Type: Notice
Date: 2008-10-17
Agency: Office of the Secretary, Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza.
Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) Stakeholders' Meeting
Document Number: E8-24732
Type: Notice
Date: 2008-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the Fire Fighter Fatality Investigation and Prevention Program (FFFIPP). Public Meeting Time and Date: 10 a.m.-5 p.m., CST, November 19, 2008. Place: Crowne Plaza Hotel, Chicago O'Hare, 5440 North River Road, Rosemont, Illinois 66018. Purpose of Meeting: The public meeting will seek stakeholder input on the progress and strategic goals of the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) to ensure that the program is meeting the needs of the stakeholders, and to identify ways in which the program can be improved to increase its impact on the safety and health of fire fighters across the United States. NIOSH will compile and consider all comments received at the meeting and through the NIOSH Docket Office and use them in making decisions on how to proceed with the FFFIPP. Status: This meeting is hosted by NIOSH and will be open to the public, limited only by the space available. The meeting room will accommodate approximately 75 people. Interested parties should make hotel reservations directly with the Crowne Plaza Hotel, telephone (847) 671-6350 or (800) 972-2494 and reference the NIOSH FFFIPP Stakeholders Meeting. Interested parties should confirm their attendance to this meeting by completing a registration form on the NIOSH Web site: http://www.cdc.gov/niosh/fire/ 2008PublicMeetingRegistration.html Format of Meeting: The NIOSH Acting Director, Dr. Christine Branche, will provide opening remarks, followed by NIOSH presentations that provide an overview of the Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) and summary of Program changes and improvements since March 2006. NIOSH will present and make available for stakeholder input a set of draft Strategic Goals for FFFIPP for stakeholder consideration and comment. Stakeholders who have requested an opportunity to speak prior to the meeting will present suggestions for enhancing the impact of the program and future directions. An opportunity to make oral presentations will be provided to all interested parties, given time on the agenda. Presentations will be limited to 10 minutes. The meeting will end with an interactive session providing the opportunity for clarification of stakeholder comments. Requests to make presentations at the meeting should be made by e- mail to Paul Moore, Chief, Fatality Investigations Team, e-mail PMoore@cdc.gov, telephone (304) 285-6016 or Matt Bowyer, General Engineer, e-mail MBowyer@cdc.gov, telephone (304) 285-5991, facsimile (304) 285-5774, before November 10, 2008. All requests to present should include the name, address, telephone number, relevant business affiliations of the presenter, and a brief summary of the presentation. After reviewing the requests for presentation, NIOSH FFFIPP staff will notify each presenter of the approximate time that their presentation is scheduled to begin. If a participant is not present when their presentation is scheduled to begin, the remaining participants will be heard in order. Written comments without an oral presentation are also encouraged, and should be submitted to the NIOSH Docket Office as outlined in the next section. Written comments on the usefulness of the FFFIPP and products for improving fire fighter safety and health, suggestions for enhancing the impact of the program, and comments on the draft FFFIPP strategic and programmatic goals may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, Mailstop C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8303, facsimile (513) 533-8285. Comments may also be submitted via e-mail to niocindocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. Comments should be submitted to NIOSH no later than December 19, 2008, and should reference the NIOSH Docket Number 063-A in the subject heading. Background: NIOSH convened a similar stakeholders' meeting in March 2006 to seek input on the progress and future directions of the FFFIPP. The input provided by stakeholders at that meeting was useful in providing insight into stakeholder needs and in helping to improve the FFFIPP. The November 2008 meeting will be held to again seek stakeholder input. Contact Person for Technical Information: Paul Moore, Chief, Fatality Investigations Team, Division of Safety Research, telephone (304) 285-6016 or Matt Bowyer, General Engineer, Fatality Investigations Team, (304) 285-5991.
Notice of Public Meeting and Availability for Public Comment
Document Number: E8-24731
Type: Notice
Date: 2008-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for the public to provide input regarding the plan (protocol) for a cohort study of persons formerly employed at the IBM facility in Endicott, New York. Public Meeting Time and Date: 9 a.m.-4 p.m., November 8, 2008. Place: Broome County Health Department, 225 Front Street, Binghamton, New York 13905. Status: The meeting is open to the public, limited only by the space available (the room accommodates approximately 120 people). Broad participation is desired. Former workers, representatives of professional societies, organized labor, employers, researchers, health professionals, and government officials are encouraged to attend. Those who cannot attend in person are encouraged to e-mail or mail comments to Dr. Douglas Trout (see below). Deadline for all comments is December 8, 2008. Participants wishing to provide stakeholder comments may do so via e-mail or may request an opportunity to make a five minute presentation. Participants making a presentation at the meeting must submit their comments in writing at the time of the meeting. All participants (whether making a presentation or not) must register for the free meeting by sending an e-mail to Dr. Douglas Trout at DTrout@cdc.gov with their name, affiliation, whether they are requesting time to speak briefly, and, if so, the general topic(s) on which they wish to speak. Participants wishing to speak are encouraged to register early. Background: In response to public interest in the conduct of a study of cancer among former workers at IBMEndicott, NIOSH conducted a feasibility effort to evaluate whether employee records were adequate to conduct a research study (a retrospective cohort mortality and cancer incidence study). This study protocol being developed makes extensive use of the information gathered during the feasibility effort, as well as a follow-up review of additional industrial hygiene, medical, and personnel records. The protocol being reviewed describes the plan for a cohort study of persons formerly employed at the IBM facility in Endicott, New York, between 1965 and 2002. The health problems to be evaluated in the proposed study include mortality and cancer incidence among workers, as well as birth defects among offspring of these workers. Approximately 28,000 workers were employed by IBMEndicott for at least one year during the period between 1965 and 2002. The meeting will consist of two parts: (1) External peer review of the research protocol. Peer reviewers external to CDC will be present to provide their individual technical (scientific) review comments for the project officers to maximize the relevance and quality of the proposed research; and (2) Stakeholder meeting. The latter part of the meeting will be structured to hear stakeholder comments on important occupational safety and health issues related to this research. Contact Person for Technical Information: Dr. Douglas Trout, MD, MHS, Associate Director for Science, Division of Surveillance, Hazard Evaluations, and Field Studies, NIOSH, telephone (513) 841-4428. Comments, meeting registrations, and requests for a copy of the protocol may be e-mailed to DTrout@cdc.gov or sent via mail to Dr. Douglas Trout, NIOSH, 4676 Columbia Parkway, Mailstop R12, Cincinnati, Ohio 45226.
Notice of Request for Public To Submit Comments and Attend Meeting
Document Number: E8-24728
Type: Notice
Date: 2008-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following notice of public meeting and draft document available for public comment entitled ``NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium.'' The document and instructions for submitting comments can be found at http://www.cdc.gov/niosh/review/public/144/. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: October 15, 2008-January 31, 2009. Public Meeting Time and Date: 9 a.m.-4 p.m. EST, January 22, 2009. Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, OH 45226-1998. Purpose of Meeting: To discuss and obtain comments on the draft document, ``NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium.'' Special emphasis will be placed on discussion of the following: 1. Are the critical studies presented clearly and adequately? 2. Do all of the presented studies use scientifically valid methods and techniques? 3. Are there additional critical studies relevant to occupational exposure to hexavalent chromium compounds that should be included? 4. Does NIOSH have a transparent and sound basis for its revised Recommended Exposure Limit for hexavalent chromium compounds? 5. Is the new NIOSH policy of providing general exposure assessment recommendations instead of a specific Action Level scientifically justified? 6. Are the NIOSH recommendations for worker protection clear and justified? 7. Are there additional recommendations for worker protection that should be included? 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 meeting room accommodates 80 people. Due to limited space and security clearance requirements, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than January 7, 2009 for U.S. citizens, or no later than December 30, 2008 for non-U.S. citizens.* Persons wanting to provide oral comments at the meeting are requested to notify the NIOSH Docket Office no later than January 7, 2009 at (513) 533-8611 or by e-mail at nioshdocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first- come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting must also be submitted to the docket in writing in order to be considered by the Agency. Written comments will also be accepted at the meeting. Written comments may also be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone (513) 533-8611. All material submitted to the Agency should reference Docket Number NIOSH-144 and must be submitted by January 31, 2009 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to Docket Number NIOSH-144. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. *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 December 30, 2008. This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. 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: Background: This draft NIOSH document provides a review of the available literature and provides an update of NIOSH policies on occupational exposure to hexavalent chromium compounds including an assessment of: (1) Critical animal, human, and in vitro studies on occupational exposure to hexavalent chromium; (2) relevant quantitative risk assessments about occupational exposure to hexavalent chromium; (3) appropriate methods for sampling and analysis of hexavalent chromium compounds in the workplace; (4) basis for the NIOSH revised Recommended Exposure Limit for hexavalent chromium compounds; and (5) other NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium. This guidance document does not have the force and effect of law. The purpose of the public review of the draft document and public meeting is to obtain public comments assessing whether: (1) This hazard identification is an accurate reflection of the available scientific studies; (2) the NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium compounds are appropriate and justified, and (3) NIOSH has a transparent and scientific basis for its revised Recommended Exposure Limit for hexavalent chromium compounds.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Temporary Marketing Permit Applications
Document Number: E8-24671
Type: Notice
Date: 2008-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Temporary Marketing Permit Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-24647
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-24646
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-24616
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-24615
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: E8-24614
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Loan Repayment Program
Document Number: E8-24587
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days 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 previously published in the Federal Register (73 FR 29520) on May 21, 2008 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 directly to OMB. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917- 0014, ``Indian Health Service Loan Repayment Program.'' Form Number(s): The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS Loan Repayment Program. A two-year contract obligation is signed by both parties, and the individual agrees to work at an IHS location and provide health services to Native American and Alaska Native individuals. The information collected from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant takes employment at a location, they in turn ``pick-up'' the score of that location. 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, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: E8-24450
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-24449
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-24448
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-24447
Type: Notice
Date: 2008-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Possession, Use, and Transfer of Select Agents and Toxins
Document Number: E8-24623
Type: Rule
Date: 2008-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document completes the biennial review and republication of the lists of biological agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA). Because USDA has chosen to no longer regulate ten biological agents and toxins which HHS still believes have the potential to pose a severe threat to public health and safety, we have moved those ten biological agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section of the select agent regulations. In a companion document published in this issue of the Federal Register, the USDA has established corresponding final rules regarding the select agents and toxins regulated only by the USDA, as well as those overlap select agents and toxins regulated by both agencies.
National Center for Research Resources; Notice of Closed Meetings
Document Number: E8-24619
Type: Notice
Date: 2008-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: E8-24612
Type: Notice
Date: 2008-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: E8-24611
Type: Notice
Date: 2008-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-24568
Type: Notice
Date: 2008-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control/ Initial Review Group, (NCIPC/IRG)
Document Number: E8-24565
Type: Notice
Date: 2008-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services