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

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following public meeting to discuss NIOSH's Respirator Standards Development Efforts and the Personal Protective Technology (PPT) Program Action Planning Efforts.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m. on December 15, 2008, and from 8:30 a.m. to 3:30 p.m. on December 16, 2008, at the Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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: Jusan Yang, M.S., M.D., University of Iowa: Based on the report of an investigation conducted by the University of Iowa (UI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, this settlement resolves proposed U.S. Public Health Service (PHS) findings that Dr. Jusan Yang, former Assistant Research Scientist, UI, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL48058. PHS finds the Respondent engaged in scientific misconduct by falsifying and fabricating data that were reported in a scientific manuscript intended for publication entitled ``Increased renin transcription after inhibition of NF-YA with RNAi reveals through regulation of Ea element and Ear2'' and at two professional scientific meetings. Specifically, PHS found that: 1. Respondent falsified Figure 1 in the manuscript that purports to show the effectiveness of four plasmids targeting different parts of the NF-Y coding sequence in inhibiting NF-Y expression by (1) Claiming in Figure 1A that the loading control bands were obtained by reprobing a Western blot with antibody to GAPDH when he used a prominent background (nonspecific) band from the blot probed with antibody to NF- YA, (2) inappropriately enhancing and manipulating the NF-YA band in Figure 1A claiming decreased expression of NF-YA in cultures transfected with 2 of the 4 constructs, and (3) falsely claiming in Figure 1B that the quantitative data for NF-YA expression obtained by scanning Western blot films were based on an n of 4 and that the expression of NF-YA in cultures treated with two constructs was statistically significantly lower than the control. Versions of the same falsified blot and histogram also were reported in several of the Respondent's public presentations. 2. Respondent falsified Figures 4, 5, 6, and 8 in the manuscript by claiming in the figure legends that 4 independent repetitions contributed to each figure's results when the actual numbers of repetitions were n=3 for Figure 4, n=1 for Figure 5, n=3 for Figure 6, and n=2 for Figure 8; in Figure 5, error bars based on the Student's t test further falsely claim that n was >2. He further falsified Figures 6 and 8 by reporting smaller standard errors of the mean than were obtained from the actual data, thereby giving an enhanced impression of rigor for the reported experiments. Respondent reported Figures 5, 6, and 8 (without legends) at the American Heart Association Council for High Blood Pressure meeting in September 2003, and he reported Figures 5 and 8 at the Experimental Biology meeting in April 2004. Respondent stated that he does not intend to apply for or engage in PHS-supported research. However, if such a circumstance were to arise, Respondent agreed for a period of five (5) years, beginning on October 14, 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 which uses him in any capacity on PHS supported research, or that submits a report of PHS funded research in which he is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution; Respondent agreed to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agreed that he will not participate in any PHS- supported research until such a supervision plan is approved by ORI; (2) That any institution employing the Respondent submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which he 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, procedures, and methodology are accurately reported in the application or report; the Respondent must ensure that the institution also sends a copy of the 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.

This notice sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services, effective on January 1, 2009.

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 Cancer Institute (NCI), 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: Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this questionnaire is to obtain information on the 5-year survival status of kidney cancer patients that were enrolled in a Central European Case-Control Study of Kidney Cancer that was conducted between 2001-2004. The aim is to assess survival, the prevalence of recurrent disease and progression, and to investigate patient, tumor and genetic determinants of survival among cases. The questionnaire will collect information on patient related factors, tumor related factors not collected during the initial study, and the type of treatment(s) received since the patients were last contacted for the case-control study. This questionnaire adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a-1) and section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Individuals that had previously participated in the Central European Renal Cancer Case-Control Study between 2001-2004 and physician abstractors. The estimated total annual burden hours requested is 296. The annualized cost to respondents is estimated at $5174. There are no additional capital costs, operating costs, and/or maintenance costs to report.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``AHRQ Healthcare Innovations Exchange Innovator Interview and AHRQ Healthcare Innovations Exchange Innovator E-mail Submission Guidelines.'' 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 August 2008 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

This document contains a technical correction to the list of select 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) published on October 16, 2008, in the Federal Register (73 FR 61363). This correction inserts ``Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments (Reconstructed 1918 Influenza virus)'' that was inadvertently omitted from the list of agents and toxins regulated by only HHS.

This notice announces a listening session being conducted by the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention to solicit informal comments on hospital- acquired conditions (HACs) and hospital outpatient healthcare- associated conditions (HOP-HACs) in preparation for the fiscal year (FY) 2010 inpatient prospective payment systems (IPPS) and calendar year (CY) 2010 outpatient prospective payment system (OPPS) rulemaking processes. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and other interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. Verbal comments will be taken from telephone participants as time permits. This meeting is open to the public, but registration is required. Further information regarding this listening session will be posted on the HAC section of the CMS Web site at http:/ /www.cms.hhs.gov/HospitalAcqCond/01_Overview.asp and the OPPS section of the CMS Web site at https://www.cms.hhs.gov/hospitaloutpatientpps/.

SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Army Research Institute of Infectious Diseases (USAMRIID). This MOU identifies the terms of collaboration between FDA and USAMRIID in the area of emergency preparedness. Specifically this MOU provides for the sharing of information and collaborative activities related to biological threat agents and diagnostics to detect such biological threat agents in order to assist both parties in more efficiently preparing for and responding to emergencies in which such diagnostic tests may be used.

The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food additive petition filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ.

The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products'' (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the same title (69 FR 21778, April 22, 2004) (proposed rule). This final rule affirms the interim final rule's requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act). The statement includes a toll- free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). This final rule also affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (the BPCA) and the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-fifth meeting, at which it will discuss three topics: exercises of conscience in the practice of the health professions, the problem of medical futility, and the future of public bioethics and national bioethics commissions in the United States. Subjects discussed at past Council meetings (although not on the agenda for the November 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, standards for the determination of death, children and bioethics, and lifespan-extension among others. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports are forthcoming on four topics: controversies in the determination of death; organ donation, procurement, allocation, and transplantation; newborn screening; and medical care and the common good.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.

The Food and Drug Administration (FDA) is proposing to withdraw approval of the following abbreviated new drug applications (ANDAs) for drug products containing polyethylene glycol 3350 (PEG 3350) labeled for prescription only use: ANDA 76-652 held by Schwarz Pharma, Inc.; ANDA 77-736 held by Kali Laboratories, Inc.; ANDA 77-706 held by Nexgen Pharma Inc. (formerly known as Anabolic Laboratories, Inc.); ANDA 77-893 held by Coastal Pharmaceuticals, Inc.; and ANDA 77- 445 held by Teva Pharmaceutical Industries, Ltd. (collectively, the PEG 3350 ANDAs). The proposal is based on the switch of MiraLax from prescription only (``Rx only'') to over-the-counter (OTC) use. This switch was pursuant to the submission of a new drug application (NDA) for MiraLax (NDA 22-015), which was approved by the agency on October 6, 2006, establishing that PEG 3350 may be used safely and effectively without the supervision of a licensed healthcare professional. The Federal Food, Drug, and Cosmetic Act (the act) does not permit both Rx and OTC versions of the same drug product to be marketed at the same time. Under the act, a drug to which the prescription provisions of the act do not apply (i.e., an OTC drug) shall be deemed to be misbranded if at any time prior to dispensing the label of the product bears the ``Rx only'' symbol. Because the PEG 3350 generic drug products are labeled as Rx only, they are misbranded and may not be legally marketed. Thus, FDA is proposing to withdraw their approval.

This proposed notice announces the receipt of an application from the American Association of Diabetes Educators (AADE) for recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. The statute requires that the Secretary publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The AHRQ Data Inventory.'' 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 notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services. This meeting is open to the public.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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).

The Food and Drug Administration (FDA) is requesting assistance in the identification of types of FDA-regulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the leaching of BPA from the packaging to the product and/or from the product from the product following human administration.