Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).'' The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. The guidance provides references to information on critical tolerances that should be achieved with mechanical calibration.

The Food and Drug Administration (FDA) is classifying the remote medication management systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System,'' which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian noninstitutionalized population. To add to the extensive amount of information collected for the purpose of describing the health of the population, DNA specimens were collected during two NHANES surveys. DNA is available in the form of crude lysates of cell lines derived from approximately 7,157 participants enrolled in Phase II of NHANES III (1991-1994). In addition, DNA purified from whole blood is also available from approximately 7,900 participants enrolled in the 1999-2002 NHANES survey years. All specimens (NHANES III and NHANES 1999-2002 were sent to the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH) for processing. DNA samples from these specimens are being made available to the research community for genetic analyses. No funding is provided as part of this solicitation. NCHS will begin to accept proposals after the publication of this notice and will continue to accept proposals on an on-going basis. Proposals received within 60 days of the notice will complete review approximately 180 days after the notice is published. After this initial review of proposals, all proposal categories will be reviewed twice a year beginning January 1 and July 1 of each year. Unforeseen circumstances could result in a change to this schedule. Proposals will be reviewed by a technical panel and by an internal Secondary Review Committee of senior CDC scientists. The Secondary Review Committee will perform a programmatic review based on the results of the technical review panel and consider the scientific and technical results from the first level of review, important programmatic considerations such as program priorities, program relevance, and other criteria germane to this announcement and to CDC. Projects approved by both reviews will be submitted to the NCHS Ethics Review Board for final approval. Approved projects that do not obtain funding on their own will be canceled. A more complete description of this program follows.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-first meeting, at which it will continue (1) its inquiry into the ``crisis'' of the healing professions with expert presentations and Council discussions; and (2) its inquiry into the moral foundations of health care. Subjects discussed at past Council meetings (although not on the agenda for the November 2007 meeting) include: Therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, personalized medicine, and lifespan-extension. 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 ResponsibilityL: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005). Reports on (a) the bioethical significance of the concept of human dignity, (b) controversies in the determination of death, and (c) organ procurement, transplantation, and allocation are forthcoming.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

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.

This notice announces the first demonstration site for the Medicare Clinical Laboratory Services Competitive Bidding Demonstration project and the date for the Bidder's Conference. The Medicare Clinical Laboratory Competitive Bidding Demonstration was mandated by the Congress. Section 302(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires the Centers for Medicare & Medicaid Services (CMS) to conduct a demonstration project on the application of competitive acquisition for clinical laboratory services that would otherwise be paid under the Medicare Part B fee schedule. The objective of the demonstration is to determine whether competitive bidding can be used to provide Part B clinical laboratory services at fees below current Medicare payment rates while maintaining quality and access to care. The MMA specifically requires that the demonstration: (1) Includes tests paid under the Medicare Part B Clinical Laboratory Fee Schedule; (2) excludes entities that have a ``face-to-face encounter'' with the patient; (3) excludes Pap smears and colorectal cancer screening tests; and, (4) includes requirements under the Clinical Laboratory Improvement Amendments (CLIA) program. An initial Report to the Congress was submitted April 2006. Site(S): The fundamental criteria for selecting demonstration sites require that each Metropolitan Statistical Area (MSA) allows for potential Medicare program savings from the demonstration, is administratively feasible, represents the laboratory market, and will yield demonstration results that can be generalized to other MSAs. The first demonstration site will be the San Diego-Carlsbad-San Marcos, California MSA. A Bidders Conference is planned for October 31, 2007 in the San Diego-Carlsbad-San Marcos, California MSA. The demonstration covers tests provided to beneficiaries enrolled in the traditional fee-for-service (FFS) Medicare program who reside in the area of the demonstration site or competitive bid area (CBA) during the 3 year demonstration period. Beneficiaries who travel outside the CBA during the demonstration period and require laboratory services will be able to access services from most laboratories in the United States. We will not directly pay, however, for services furnished by a required bidder that did not bid or bid and did not win or a non- required bidder that bid and did not win. (The terms ``required bidder'' and ``non-required bidder'' are explained in section II below.) Laboratories may not bill beneficiaries for laboratory services covered under the Medicare program.

The Food and Drug Administration (FDA) is seeking comment on whether to withdraw its guidance document entitled ``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.'' FDA is considering withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of a draft ``White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated with Such Exposure,'' the availability of which is announced elsewhere in this issue of the Federal Register.

The ACHDGDNC will be conducting a two hour conference call to hear a presentation from the ACHDGDNC's Evidence Review Workgroup and discuss the Committee's Report on long-term followup.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval.'' The purpose of this guidance is to inform industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and to ask sponsors to amend ongoing or completed studies accordingly. This guidance is in response to a number of public discussions in recent years regarding the use of active-controlled studies designed to show noninferiority as a basis for approval of antibacterial drug products.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This draft guidance document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

The Health Resources and Services Administration published a notice in the Federal Register of August 29, 2007, requesting comments on draft Agency Guidance (Policy Information Notices (PINS)) to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project. The PINS, ``Defining Scope of Project and Policy for Requesting Changes,'' ``Changes in Scope Requests: Policy for Adding a New Target Population,'' and ``Specialty Services and Health Centers' Scope of Project,'' are available on the Internet at https:// bphc.hrsa.gov. Correction: In the Federal Register of August 29, 2007, FR Doc. E7- 17092, on page 49724, in the first column, under DATES, the deadline for comments has been extended to October 19, 2007.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2008. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2008 for application fees for an application requiring clinical data ($1,178,000), for an application not requiring clinical data or a supplement requiring clinical data ($589,000), for establishment fees ($392,700), and for product fees ($65,030). These fees are effective on October 1, 2007, and will remain in effect through September 30, 2008. For applications and supplements that are submitted on or after October 1, 2007, the new fee schedule must be used. Invoices for establishment and product fees for FY 2008 will be issued in October 2007, using the new fee schedule.

This notice announces the 20th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 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.

This notice announces the tenth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 13th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

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 renewal of the generic information collection project: ``Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality'' 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 August 3, 2007 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.

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 thirteenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 15, 2007, and from 9 a.m. to 3 p.m. on November 16, 2007, at the Crowne Plaza Hotel Washington, DCSilver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-321-2007 ``Second Generation Improved Spiral Tube Support for Countercurrent Chromatography'' to CC Biotech LLC, a company incorporated under the laws of the State of Maryland having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and components for centrifugal or countercurrent chromatographic purification, isolation, or preparation of biomolecules and macromolecules.

The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces the awarding of fifty supplemental awards in the amount of $5,733,115 to Fiscal Year (FY) 2006 Mentoring of Children of Prisoners (MCP) grantees. Section 439 of the Social Security Act, as amended by the Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) authorizes the Secretary of Health and Human Services (HHS) to award grants for the purpose of supporting the establishment or expansion and operation of community-based programs to provide one-on-one mentoring relationships between a child of incarcerated parent(s) and a caring, supportive adult mentor under the Mentoring Children of Prisoners Program (MCP). The program is designed to reach the President's goal of establishing 100,000 mentor/mentee relationships between a caring adult and a young person whose parent(s) is incarcerated in a correctional facility by the end of FY 2008. This funding is requested for those grantees that have demonstrated the capacity to make quality matches and currently making significant process in reaching their match goal. One-third of the grantees have made over 50% of their three-year match goal within their first year. The fifty supplemental awards are important to helping our grantees reach more youth who are in need of a mentor. The following agencies are receiving grant funds for a twelve month project period:

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces the approval of a deviation to supplement the National Runaway Switchboard for the purpose of expanding their services. Congress authorized the establishment of a ``national communications system to assist runaway and homeless youth in making contact with their families and service providers'' through the Runaway and Homeless Youth Act (RHYA) of the Juvenile Justice and Delinquency Prevention Act of 1974, as amended. Funding for the system was first authorized in fiscal year 1980. (The system currently is authorized through Part C, section 331, of the ``Runaway, Homeless, and Missing Children Protection Act,'' Pub. L. 108-96.) The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces an expansion supplement award to the National Runaway Switchboard (NRS) for two initiatives; a comprehensive research project on runaway and at-risk youth and a comprehensive database conversion. The results of the comprehensive research project will enable NRS to better understand how to communicate with youth and develop strategies to connect with them and them with the NRS. The comprehensive database conversion will enhance the Switchboard's capability to download and manage information. This project will provide the NRS with the internal controls necessary to query and analyze data collected in their crisis logs. It is anticipated that the enhanced internal controls will result in a significant improvement in the way needs of runaway, homeless and other youth in at-risk situations are met. This expansion supplement is for a nine month project period for the amount of $162,637.

The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA is establishing a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

This document corrects technical errors that appeared in the final rule with comment period entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates'' that appeared in the August 22, 2007 Federal Register.

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: Jon Sudb[oslash], D.D.S., Norwegian Radium Hospital: Based on the findings of an investigation conducted by the Investigation Commission appointed by Norwegian Radium Hospital (NRH) and the University of Oslo, the respondent's own admission, and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Jon Sudb[oslash], D.D.S., former doctoral student and faculty member, University of Oslo, and former physician in the Department of Medical Oncology and Radiotherapy, NRH, engaged in scientific misconduct by reporting fabricated and/or falsified research in grant application 1 P01 CA106451-01 submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), and its first-year progress report. Specifically, PHS found that Dr. Sudb[oslash] engaged in scientific misconduct by falsifying and fabricating research that served as the rationale for Project 1, ``Oral Cancer Prevention with Molecular Targeting Therapy,'' with Dr. Jon Sudb[oslash], as project leader, in the grant application, and by falsifying a progress report for the awarded grant. In particular, in Figure 1 of the Background and Significance section of the grant application, Dr. Sudb[oslash] reported fabricated/falsified results for the effects of lesion ploidy upon survival in patients with oral pre-malignant lesions. In the Preliminary Data section of the grant application, Dr. Sudb[oslash] reported several events intended to demonstrate his experience in the research field that the Investigation Commission stated ``appear as pure fiction.'' Also, in the first yearly progress report for the funded grant, Dr. Sudb[oslash] falsified the number of patients that had been screened for admission to the study. In addition to three publications for which Dr. Sudb[oslash] admitted falsifying and/or fabricating data, the Investigation Commission found at least twelve other publications that warranted retraction because they could not be considered valid. The research reported in these publications was not supported by PHS funds. However, the publications address the same general research area as that addressed in the grant application and demonstrate a pervasive pattern of falsification/fabrication in research reporting on the part of Dr. Sudb[oslash]. The falsified/fabricated data presented in the grant application purport to demonstrate the feasibility of preventing cancer in a high risk population with nontoxic oral agents. Dr. Sudb[oslash] has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, beginning on August 31, 2007: (1) To exclude himself permanently from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as delineated in the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376, et seq.; Dr. Sudb[oslash] agrees that he will not petition HHS to reverse or reduce the scope of the permanent voluntary exclusion or other administrative actions that are the subject of this Agreement; and (2) To exclude himself permanently 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.

The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, June 11, 2007 announcing the anticipated availability of funds for family planning services grants. On July 13, 2007, the Notice was corrected to reflect the availability of Arizona, Navajo Nation for competition. Since that time, an additional State/population/area to be served has become available for competition. This Notice reflects the availability of Illinois, Chicago area for competition.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA 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, a revision to bacterial pathogen nomenclature, and an increase in liver tolerance.

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2008. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2008 are $192.70 for aged enrollees and $209.70 for disabled enrollees. The standard monthly Part B premium rate for 2008 is $96.40, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2007 standard premium rate was $93.50.) The Part B deductible for 2008 is $135.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage, by the end of the 3-year transition period. However, for 2008, the beneficiary is only responsible for 67 percent of any applicable income-related monthly adjustment amount. (For 2007, the beneficiary was responsible for 33 percent of the applicable amount.)

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting and request for public input regarding a proposed survey of U.S. truck driver safety and health. The goal of the survey is to collect information on truck driver health, sleep disorders, fatigue, working conditions, and non-fatal injuries. Further information on the proposed survey may be found at: https://www.cdc.gov/ niosh/review/public/110. Public Comment Period: From date of publication of this notice until January 2, 2008. Public Meeting Date and Time: Thursday, November 1, 2007, 8:30 a.m.-4:30 p.m., CST. Place: Westin O'Hare Hotel, 6100 North River Road, Rosemont, Illinois 60018, telephone (888) 627-8517. Purpose of the Meeting: To obtain public comment on the content and conduct of a nationally representative survey of truck drivers' safety and health. Special emphasis will be placed on discussion of the following: (1) Content of the survey. (2) Appropriate methods of conducting such a survey. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 70 people. Interested parties should make hotel reservations directly with the Westin O'Hare Hotel by calling (888) 627-8517 or via the Web site at https://www.starwoodmeeting.com/Book/westatOc before the cut-off date of 5 p.m. CST October 10, 2007. A special group rate of $205.00 per night (or prevailing government rate) plus tax per night for meeting guests has been negotiated for this meeting. In order to receive the special room rate, you will need to indicate that you will be attending the NIOSH meeting. Interested parties should confirm their attendance to this meeting by contacting Ms. Mary K. Dingwall, meeting coordinator, at (301) 738- 3583 or MaryDingwall@Westat.com by October 19, 2007. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting or by submitting them to the NIOSH Docket Office. Contact Person for Technical Information: Karl Sieber, NIOSH/CDC, Robert A. Taft Laboratories, 4676 Columbia Pkwy. MS R-17, Cincinnati, OH 45226, telephone (513) 841-4231, or Stephanie Pratt, NIOSH/CDC, 1095 Willowdale Road, MS 1808, Morgantown, WV 26505, telephone (304) 285- 5992. Contact Person for Submitting Comments: Comments on the topics presented in this notice and at the meeting should be mailed to: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8450, fax (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov or at https://www.cdc.gov/niosh/review/public/110/. E-mail attachments should be formatted in Microsoft Word. All comments should be received by January 2, 2008 and should reference the Docket Number (NIOSH-110) in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226 and at https:// www.cdc.gov/niosh/docket/default.html.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The draft guidance describes a means by which the electrocardiograph electrode device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate this draft guidance as the special control for this device and would exempt the device from premarket notification requirements, subject to specific limitations, if the device addresses the issues identified in the guidance by following its recommendations. The draft guidance document is not final, nor is it being implemented at this time.

The Food and Drug Administration (FDA) is announcing that Dean Foods Co. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 as a nutrient supplement in soy-based food products.

The Food and Drug Administration (FDA) is announcing a public meeting to obtain comments regarding behind-the-counter (BTC) availability of drugs. Currently, drugs are available as prescription and non-prescription. Generally, non-prescription products are available in an ``over-the-counter'' (OTC) manner. The FDA is interested in obtaining public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist. The purpose of the meeting is to solicit information and views from interested persons on specific issues associated with BTC availability, including the impact on patient access to safe and effective drug products. Dates and Times: The public meeting will be held on November 14, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.

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 the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, 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:

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 Mound Plant, Miamisburg, Ohio, 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: Mound Plant. Location: Miamisburg, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: February 1, 1949 through the present.

The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test, in a regulatory setting, the electronic submission of nonclinical study data using the Standard for Exchange of Nonclinical Data (SEND). The purpose of this pilot is to test the ability of a new electronic data format to support nonclinical review activity. The pilot also will involve a collaboration of FDA, available pilot participants, and the SEND Consortium to update and create a new draft SEND implementation guide. FDA anticipates that a successful pilot will enable CDER to routinely accept nonclinical study data electronically in SEND format, instead of paper or portable document format (PDF), in investigational new drug applications (INDs), new drug applications (NDAs), and biologics licensing applications (BLAs).

The NTP is developing the Host Susceptibility Program (HSP), a new research program, to identify and functionally validate genes associated with environmental exposure. This program will make available NTP expertise and resources to investigate the genetic basis for population-level differences in susceptibility to environmental toxicants and/or disease based upon gene and environment interactions. This research will be designed to ultimately lead to a better understanding of why some individuals are more susceptible than others to exposure to an environmental toxicant resulting in disease and morbidity. Asthma, cardiovascular disease, cancer, diabetes, and obesity are examples of diseases associated with multiple interacting genes that are influenced by exposure to environmental agents. Through this Request for Information, extramural and intramural scientists are invited and encouraged to provide information and comment relevant to this proposed programmatic research approach in order to help guide further development and refinement of the goals of the NTP HSP. Information on this initiative can be submitted electronically through the HSP Request for Information Web site at: (https://ntp.niehs.nih.gov/ go/32130 ) or by contacting Dr. John E. French (see FOR FURTHER INFORMATION CONTACT below).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the opportunity for patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to nominate candidates to serve on the Board of Directors (the Board) of a new non-profit foundation, the Reagan-Udall Foundation for the Food and Drug Administration (the Foundation). The Foundation will be dedicated to modernizing medical, veterinary, food, food ingredient, and cosmetic product development, accelerating innovation, and enhancing product safety.

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns a new FDA foreign small business qualification certification form that will allow a foreign business to qualify as a ``small business'' and pay certain medical device user fees at reduced rates.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Forms 3503 and 3504'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. This meeting was announced in the Federal Register of August 16, 2007 (72 FR 46091). The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.

On July 31, 2007, CDC published an advanced notice of proposed rulemaking (ANPRM), ``Foreign Quarantine regulations, Proposed Revision of HHS/CDC Animal-Importation Regulations,'' (72 FR 41676) to begin the process of revising HHS/CDC Animal Importation Regulations that cover dogs and cats (42 CFR 71.51), and to consider extending these regulations to cover domesticated ferrets. The ANPRM will also address the importation of African rodents (42 CFR 71.56) into the United States. HHS/CDC is also considering the need for additional regulations to prevent the introduction of zoonotic diseases into the United States. CDC provided a 60-day pubic comment period, with written comments to be received on or before October 1, 2007. CC has received requests asking for an extension of the comment period. In consideration of these requests, CDC is extending the comment period an additional 60 days, with a new closing date of December 1, 2007.