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

Results 151 - 200 of 231
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-29149
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: E8-29148
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval-the Premarket Approval Supplement Decisionmaking Process; Availability
Document Number: E8-29330
Type: Notice
Date: 2008-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Modifications to Devices Subject to Premarket Approval (PMA)the PMA Supplement Decision-Making Process.'' The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-29322
Type: Notice
Date: 2008-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
Document Number: E8-29303
Type: Notice
Date: 2008-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance document entitled ``Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.'' This revised draft guidance is intended to assist the industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). The revised draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability
Document Number: E8-29301
Type: Notice
Date: 2008-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.'' This revised draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The revision of the draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-29280
Type: Notice
Date: 2008-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-29278
Type: Notice
Date: 2008-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: E8-29272
Type: Notice
Date: 2008-12-11
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feeds; Ractopamine
Document Number: E8-29177
Type: Rule
Date: 2008-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter; and a revision to bacterial pathogen nomenclature.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: Z8-26726
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Mallinckrodt Chemical Co., Destrehan Street Plant in St. Louis, MO, To Be Included in the Special Exposure Cohort
Document Number: E8-29247
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mallinckrodt Chemical Co., Destrehan Street Plant in St. Louis, Missouri, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mallinckrodt Chemical Co., Destrehan Street Plant. Location: St. Louis, Missouri. Job Titles and/or Job Duties: All employees who worked with uranium. Period of Employment: January 1, 1958 to December 31, 1958.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-29246
Type: Notice
Date: 2008-12-10
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Connecticut Aircraft Nuclear Engine Laboratory in Middletown, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 24, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Metallurgical Laboratory in Chicago, IL, To Be Included in the Special Exposure Cohort
Document Number: E8-29245
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Metallurgical Laboratory in Chicago, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Metallurgical Laboratory. Location: Chicago, Illinois. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: August 13, 1942 through June 30, 1946.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Vitro Manufacturing in Canonsburg, PA, To Be Included in the Special Exposure Cohort
Document Number: E8-29244
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Vitro Manufacturing in Canonsburg, Pennsylvania, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Vitro Manufacturing. Location: Canonsburg, Pennsylvania. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: August 13, 1942 through December 31, 1957.
Quality Assurance Requirements for Respirators; Notice of Proposed Rulemaking
Document Number: E8-29236
Type: Proposed Rule
Date: 2008-12-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) proposes to update existing quality assurance requirements under 42 CFR Part 84 for the manufacture of all respirators approved by the National Institute for Occupational Safety and Health (``NIOSH'') of Centers for Disease Control and Prevetion (CDC), HHS. The proposed new requirements would require respirator manufacturers to be compliant with a widely adopted voluntary consensus standard for quality management systems, would update technical requirements particular to quality assurance for manufacturing of NIOSH-approved respirators, and would establish requirements governing the related quality assurance oversight activities of NIOSH.
Approval Tests and Standards for Closed-Circuit Escape Respirators; Notice of Proposed Rulemaking
Document Number: E8-29235
Type: Proposed Rule
Date: 2008-12-10
Agency: Department of Health and Human Services
This notice proposes updated requirements that the Department of Health and Human Service's (HHS), Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) would employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under 42 CFR pt. 84, Approval of Respiratory Protective Devices. NIOSH also approves these respirators used in other work environments where escape equipment may be provided to workers, such as vessels operated by U.S. Navy and Coast Guard personnel. The proposed rule would replace only those technical requirements in 42 CFR Part 84Subpart H that are uniquely applicable to closed-circuit escape respirators (CCERs), a subset of the variety of escape respirators presently covered by Subpart H. All other applicable requirements of 42 CFR Part 84 would remain unchanged. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs.
Findings of Scientific Misconduct
Document Number: E8-29203
Type: Notice
Date: 2008-12-10
Agency: Office of the Secretary, Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Homer D. Venters, Jr., M.D., University of Illinois at Urbana- Champaign: Based on the report of an investigation conducted by the University of Illinois at Urbana-Champaign (UIUC) and extensive additional image analysis conducted by the Office of Research Integrity (ORI), the U.S. Public Health Service (PHS) found that Dr. Homer D. Venters, former graduate student, Neuroscience Program, UIUC, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), awards R01 MH051569 and F30 MH12558 and National Institute on Aging (NIA), NIH, award R01 AG06246. Specifically, PHS found that the Respondent committed misconduct in science: By intentionally and knowingly preparing and including duplicate image data in Figures 5 and 10 of PHS fellowship application F31 MH12558, ``Neurodegeneration via TNF-alpha inhibition of IGF-1,'' submitted in 1999, which was funded as F30 MH12558 from June 1, 2000, to May 31, 2003. Because the duplicate data were labeled as having been obtained from different experiments, the results for at least one of the two figures were intentionally falsified and constitute an act of scientific misconduct. By intentionally and knowingly preparing and including duplicate image data in Figure 3 and/or 4 of a manuscript submitted and published as: Venters, H.D., et al. ``A New Mechanism of Neurodegeneration: A Proinflammatory Cytokine Inhibits Receptor Signaling by a Survival Peptide.'' Proceedings of the National Academy of Sciences U.S.A. 96:9879-9884, 1999. By preparing and providing to his dissertation committee in March 2000 a thesis proposal entitled ``An Alternate Mechanism of Neurodegeneration: Silencing of Insulin-like Growth Factor-I survival signals by Tumor Necrosis Factor-[alpha],'' which contained five falsified figures: Figures 1.3, 1.4a, 2.1b, 2.3e, and 2.5b. In each figure, he reused data within the same figure or in another thesis proposal figure as representing differently treated samples or as data obtained with different immunoblotting antisera. In March and April 2001, Respondent included several of the same falsified figures as in the thesis proposal and multiple additional falsified figures in his dissertation ``Silencing of Insulin-like Growth Factor I Neuronal Survival Signals by Tumor Necrosis Factor-[alpha].'' In all, Figures 3.3, 3.4a, 3.4b, 4.1b, 4.3a, 4.5b, 5.1a, 5.2, 5.4a, 5.5a, 5.6a, 5.7a, and 5.8a were falsified. In each instance, he assembled figures by reusing significant data, on some occasions after manipulating the orientation of the data, either within the same figure or in other figures related to his thesis and represented the data falsely as coming from different samples or different experiments. Dr. Venters has entered into a Voluntary Settlement Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on November 19, 2008: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses the Respondent in any capacity on PHS- supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for monitoring of the Respondent's research to the funding agency and ORI for approval; the monitoring plan must be designed to ensure the scientific integrity of the Respondent's research contribution; Respondent agreed that he will not participate in any PHS-supported research until such a monitoring plan is submitted to ORI and the funding agency; (2) That Respondent will ensure that any institution employing him will submit to ORI, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data analyses, procedures, and methodology are accurately reported in the application or report; Respondent must ensure that the institution sends a copy of each certification to ORI; and (3) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS. Respondent also voluntarily agreed that within 30 days of the effective date of this Agreement: (4) He will submit a letter to the journal editor, with copies to his coauthors, identifying his falsification of Figures 3 and/or 4 in the following article: Venters et al. ``A New Mechanism of Neurodegeneration: A Proinflammatory Cytokine Inhibits Receptor Signaling by a Survival Peptide.'' Proceedings of the National Academy of Sciences 96:9879-9884, 1999.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-29202
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Collection: Comment Request; Revision of OMB No. 0925-0001/exp. 1/30/10, “Research and Research Training Grant Applications and Related Forms”
Document Number: E8-29147
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services, National Institutes of Health
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, the Office of Extramural Research, 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: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 11/30/10. Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. Need and Use of Information Collection: The application is used by applicants to request Federal assistance for research and research- related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or Households; Business or other for- profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 160,135; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 14; and Estimated Total Annual Burden Hours Requested: 2,251,500. The estimated annualized cost to respondents is $78,802,500. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-29146
Type: Notice
Date: 2008-12-10
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Blood Products Advisory Committee; Notice of Meeting
Document Number: E8-29105
Type: Notice
Date: 2008-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-29033
Type: Notice
Date: 2008-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-29031
Type: Notice
Date: 2008-12-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine; Notice of Meeting
Document Number: E8-29030
Type: Notice
Date: 2008-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Health Promotion/Disease Prevention Grantee Survey
Document Number: E8-28922
Type: Notice
Date: 2008-12-09
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 23254) on August 25, 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-NEW, ``Indian Health Service Health Promotion/Disease Prevention Grantee Survey.'' Type of Information Collection Request: This is a one-time survey to fulfill an OMB request for an independent external evaluation collection, 0917-NEW, ``Indian Health Service Health Promotional Disease Prevention (HP/DP) Grantee Survey.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. HP/DP is one of the three IHS Director's initiatives to reduce health disparities among AI/AN populations through a coordinated and systematic approach to enhance health promotion and chronic disease prevention approaches at the local, regional, and national levels. The HP/DP competitive grant was established in 2005 to encourage Tribal and urban Indian programs to fully engage their local schools, communities, health care providers, health centers, faith-based/ spiritual communities, senior centers, youth programs, local governments, academia, non-profit organizations, and many other community sectors to work together to enhance and promote health and prevent chronic disease in their communities. Thirty-three Tribal/urban Indian organizations and programs were awarded competitive grants to expand and enhance health promotion and disease prevention to address health disparities among AI/AN populations. To conduct a thorough evaluation of the grant program, 29 telephone and four face-to-face interviews will be conducted to collect information to complete a quantitative and qualitative evaluation of the HP/DP grant program. The teleconference interviews may include one staff member per site. Each of the Tribal/urban organization/programs will determine the number of their staff members that will participate in the interview. The evaluation will include an assessment of whether HP/DP grantees achieve measurable health outcomes, synthesize the evaluation findings, and include a written report with recommendations to enhance program effectiveness. The information gathered will be used to prepare a final report for OMB. Affected Public: Individuals. Type of Respondents: Tribal/urban organizations program staff. 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).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28902
Type: Notice
Date: 2008-12-09
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Establishing Benchmarks for the Medical Office Survey on Patient Safety.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 19th, 2008 and allowed 60 days for public comment. One comment was received. This notice differs from the previous notice in that the number of respondents was increased by 150 respondents and the burden hours were reduced by 1,488 hours. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28901
Type: Notice
Date: 2008-12-09
Agency: Department of Health and Human Services, Agency for Health Care Research and Quality, Agency for Healthcare Research and Quality
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ``Overcoming Barriers to Expanded Health Information Exchange (HIE) Participation in Indiana.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 10th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Child Support Enforcement Program
Document Number: E8-28660
Type: Rule
Date: 2008-12-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
These rules implement provisions of title IV-D of the Social Security Act (the Act) as amended by the Deficit Reduction Act of 2005, Public Law 109-171 (DRA). The rules address use of the Federal tax refund offset program to collect past-due child support on behalf of children who are not minors, mandatory review and adjustment of child support orders for families receiving Temporary Assistance for Needy Families (TANF), reduction of the Federal matching rate for laboratory costs incurred in determining paternity, States' option to pay more child support collections to former-assistance families, and the mandatory annual $25 fee in certain child support enforcement (IV-D) cases in which the State has collected and disbursed at least $500 of support to the family. The rules also make other conforming changes necessary to implement changes to the distribution and disbursement requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28648
Type: Notice
Date: 2008-12-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Uniform Compliance Date for Food Labeling Regulations
Document Number: E8-28920
Type: Rule
Date: 2008-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing January 2, 2012, as the uniform compliance date for food labeling regulations that are issued between January 1, 2009, and December 31, 2010. (January 1, 2012, falls on a Sunday; therefore, the uniform compliance date will be January 2, 2012). FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 21, 2006, FDA established January 1, 2010, as the uniform compliance date for food labeling regulations issued between January 1, 2007, and December 31, 2008.
Risk Communication Advisory Committee; Notice of Meeting
Document Number: E8-28887
Type: Notice
Date: 2008-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
http:// www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides .htm). Finally, PPIs are also required for some drugs and are considered part of the approved product labeling, for example, for estrogens and oral contraceptives. FDA will seek the advice of the advisory committee, and commentary from stakeholders and from the public, for consideration as it considers appropriate next steps to improve the communication of information about prescription drugs to patients. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is or will be available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 19, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 3 p.m. on February 26 and between approximately 10:30 a.m. and 11:30 a.m. on February 27. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 19, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 20, 2009. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Child Support Enforcement Program; Intergovernmental Child Support
Document Number: E8-28812
Type: Proposed Rule
Date: 2008-12-08
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
These proposed regulations would revise Federal requirements for establishing and enforcing intergovernmental support obligations in Child Support Enforcement (IV-D) program cases receiving services under title IV-D of the Social Security Act (the Act). The proposed changes would: Revise current interstate requirements to apply to case processing in all intergovernmental cases; require the responding State IV-D agency to pay the cost of genetic testing; clarify responsibility for determining in which State tribunal a controlling order determination is made where multiple support orders exist; recognize and incorporate electronic communication advancements; and make conforming changes to the Federal substantial-compliance audit and State self-assessment requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-28814
Type: Notice
Date: 2008-12-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Board of Scientific Counselors, National Center for Health Marketing (BSC, NCHM)
Document Number: E8-28813
Type: Notice
Date: 2008-12-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments
Document Number: E8-28797
Type: Notice
Date: 2008-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: E8-28736
Type: Notice
Date: 2008-12-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: E8-28746
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E8-28745
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: E8-28743
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: E8-28731
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-28729
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-28728
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Cancer Institute; Amended Notice of Meeting
Document Number: E8-28727
Type: Notice
Date: 2008-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices
Document Number: E8-28695
Type: Notice
Date: 2008-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reclassification petitions for medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substances Notification System
Document Number: E8-28694
Type: Notice
Date: 2008-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability
Document Number: E8-28693
Type: Notice
Date: 2008-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics,'' dated November 2008. The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under the U.S. Public Health Service Act (PHS Act). The guidance describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements. The guidance announced in this notice finalizes the draft guidance of the same title.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
Document Number: E8-28692
Type: Notice
Date: 2008-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC
Document Number: E8-28690
Type: Notice
Date: 2008-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls. Specific elements of the MOU include the creation of an FDA/WebMD online resource on the WebMD.com site, which will feature editorial and visual FDA Consumer Health Information, and the inclusion of FDA Consumer Health Information in at least three issues per year of WebMD The Magazine. An agency policy statement summarizing the criteria and processes for development of this type of collaboration is available on FDA's Web site at www.fda.gov/consumer/co_brandpolicy.html.