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

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Document Number: E8-17577
Type: Notice
Date: 2008-07-31
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.
[Docket No. FDA-2008-N-0094]
Document Number: E8-17576
Type: Notice
Date: 2008-07-31
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entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-17569
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-17568
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities-Survey
Document Number: E8-17566
Type: Notice
Date: 2008-07-31
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.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: E8-17564
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Collection; Comment Request
Document Number: E8-17528
Type: Notice
Date: 2008-07-31
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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. 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.
National Center for Research Resources; Notice of Closed Meetings
Document Number: E8-17525
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meeting
Document Number: E8-17524
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-17523
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: E8-17521
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-17518
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-17517
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Workgroup Meeting
Document Number: E8-17513
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-17510
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E8-17508
Type: Notice
Date: 2008-07-31
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-17506
Type: Notice
Date: 2008-07-31
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.
Proposed Data Collection; Comment Request; Public Health Service; The National Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) (NCI)
Document Number: E8-17505
Type: Notice
Date: 2008-07-31
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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 National Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS); Type of Information Collection Request: NEW; Need and Use of Information Collection: The purpose of SPARCCS is to identify the beliefs, knowledge, attitudes, and practices of primary care physicians and cancer specialists regarding the components described by the Institute of Medicine's (IOM) 2005 report that described the essential components of cancer survivorship care within a health care delivery system. These data will inform the process of standardization of survivorship care practices; augment the data collected in other cancer survivorship studies such as the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), and the Cancer Research Network; and monitor the progress made toward achieving NCI strategic goals of improving the quality of cancer care across the cancer control continuum. Two questionnaires, one sent to primary care physicians and one sent to medical oncologists, will be administered by mail to a randomly selected national sample of 2,200 physicians. Study participants will be 1,100 practicing physicians who are family practitioners, general internists, and obstetrician/gynecologists and 1,100 medical oncologists. Frequency of Response: Once. Affected Public: Individuals and Businesses. Type of Respondents: Primary care and medical oncology physicians practicing in a non-federal facility. The annual reporting burden is estimated at 903 hours as shown in Table 1. The total burden hours is estimated at 1,808 hours over the two year field period of the study. There are no capital, operating or maintenance costs to report.
Draft Guidance for Industry: Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products; Availability
Document Number: E8-17431
Type: Notice
Date: 2008-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products,'' dated July 2008. The draft guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in- process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The draft guidance also recommends how to report to the FDA implementation of parvovirus B19 NAT.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-17419
Type: Notice
Date: 2008-07-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-17418
Type: Notice
Date: 2008-07-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Coordinating Office for Terrorism Preparedness and Emergency Response
Document Number: E8-17417
Type: Notice
Date: 2008-07-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-17371
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: E8-17353
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-17352
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-17300
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-17260
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: E8-17259
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-17258
Type: Notice
Date: 2008-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Blood Products Advisory Committee; Notice of Meeting
Document Number: E8-17359
Type: Notice
Date: 2008-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Food and Drug Administration Amendments Act of 2007; Prohibition Against Food to Which Drugs or Biological Products Have Been Added; Request for Comments
Document Number: E8-17356
Type: Notice
Date: 2008-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting comments relevant to the implementation of section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. FDA requests that interested persons submit data, information, and comments that will help provide a context for the agency's decisions on implementation of this provision. To encourage responsive comments, FDA is including a series of questions for interested persons to consider in preparing comments.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-17354
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget
Document Number: E8-17336
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: E8-17314
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services
This notice announces the 29th meeting of the American Health Information Community Population Health and Clinical Care Connections 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 Confidentiality, Privacy, & Security Workgroup Meeting
Document Number: E8-17313
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services
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.).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability
Document Number: E8-17305
Type: Notice
Date: 2008-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft information sheet guidance entitled ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions.
Risk Communication Advisory Committee; Notice of Meeting
Document Number: E8-17304
Type: Notice
Date: 2008-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
Document Number: E8-17303
Type: Notice
Date: 2008-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error.
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
Document Number: E8-17298
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services
This notice announces the 19th 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 Consumer Empowerment Workgroup Meeting
Document Number: E8-17297
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services
This notice announces the 28th 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.).
Developmental Disabilities Program
Document Number: E8-17296
Type: Proposed Rule
Date: 2008-07-29
Agency: Department of Health and Human Services
The Administration on Developmental Disabilities (ADD) reopens the public comment period on the proposed rule published in the Federal Register on April 10, 2008 (73 FR19708) to propose clarifications and new requirements to implement the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000). During the comment period there were instances when the electronic system was not available and individuals were having difficulties using the system. ADD is reopening the comment period of the NPRM to ensure that all individuals have an opportunity to comment on the proposed rule. Also, the submission of comments electronically will now be through the OMB regulations Web site, regulations.gov, rather than ACF's regulations Web site.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-17167
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-17166
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-17165
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: E8-17044
Type: Notice
Date: 2008-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Opportunity for a Hearing on Compliance of Texas State Plan Provisions Concerning Payments for Birthing Center Facility Services With Title XIX (Medicaid) of the Social Security Act
Document Number: E8-17273
Type: Notice
Date: 2008-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the opportunity for an administrative hearing to be held on September 26, 2008 at the CMS Dallas Regional Office, 1301 Young Street, Room 1196, Dallas, Texas 75202, to consider whether Texas State plan provisions concerning payments for birthing center facility services comply with the requirements of the Social Security Act as discussed in the July 28, 2008 letter sent to the State and published herein.
National Cancer Institute; Notice of Closed Meetings
Document Number: E8-17245
Type: Notice
Date: 2008-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: E8-17139
Type: Notice
Date: 2008-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: E8-17137
Type: Notice
Date: 2008-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Prohibition of Midyear Benefit Enhancements for Medicare Advantage Organizations
Document Number: E8-17056
Type: Rule
Date: 2008-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule prohibits Medicare Advantage (MA) organizations, including organizations offering MA plans to employer and union group health plan sponsors, from making midyear changes to non-prescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. This final rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors and not open to general enrollment may continue to offer benefit enhancements as they do currently, through means other than midyear benefit enhancements (MYBEs). Programs of all-inclusive care for elderly (PACE) are not subject to the provisions of this final rule and may continue to offer enhanced benefits as specified in our guidance for PACE plans.