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

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 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 (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT- 01], to Aires Pharmaceuticals, Inc., a portfolio company of ProQuest Investments LLC, Princeton, N.J. The field of use of inhaled administration of nitrite salts for this exclusive license may be limited to the use of inhaled formulations of nitrite salts for the treatment of Pulmonary Hypertension and pulmonary and/or cardiopulmonary conditions. The United States of America is an assignee of the patent rights in these inventions.

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 a co-exclusive license to practice the invention embodied in Patent Applications U.S. 60/340,772, filed on 12/12/2001, U.S. 60/342,582, filed on 12/19/2001, PCT/US2002/036829, filed on 11/14/2002, and corresponding EP, CA, AU, and JP filings, as well as U.S. 10/498,416, filed on 06/10/2004; entitled ``Methods for using extracellular adenosine inhibitors and adenosine receptor inhibitors to enhance immune response and inflammation'', all by Michail V. Sitkovsky, and Akio Ohta, to Redox Therapies, Inc., having a place of business in Boston, MA. The patent rights in this invention have been assigned to the United States of America.

This notice announces the 13th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C.; App.)

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), 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: Monitoring and Evaluation of the NIDA Goes Back to School National Dissemination Campaign. Type of Information Collection Request: New. Need and Use of Information Collection: This is a request for a one-time clearance to collect information on the use of the NIDA Goes Back to School (NGBTS) dissemination materials that can be requested by interested persons from the NIDA Internet site. The National Institute on Drug Abuse (NIDA) launched an initiative to increase awareness of the Institute and its mission to bring the power of science to bear on the treatment and prevention of drug abuse and addiction. NIDA has been developing science education materials for grades K-12 for use by students, teachers, parents, school counselors, school health educators, school resources officers, community organizers, and state and local government agencies. The number of requestors has been an average of 7,500 per year. These large numbers indicate that the dissemination reach is considerable. The pattern of requests also indicates that the number of requests increases dramatically in the early weeks after a dissemination activity is launched. The purpose of this information collection is to determine the level of use by school personnel and community leaders who request the NGBTS materials, and if there is a difference in use level between those requestors responding to a campaign activity and those requestors who were not reached by campaign activities. The information will identify barriers to the use of the materials among these occupational groups and the populations they serve. It will help make the materials more productive in raising the awareness of the harms from substance abuse among children, youth, and parents. It will be used to refine the focus of the dissemination activities, so that dissemination resources are used more productively. The information will be collected from requestors who have requested NIDA NGBTS materials using the requestor forms from the NIDA site, from October 2003 to September 2005. All information collection in the evaluation will be conducted on-line. The estimated total time for a survey is 5 minutes. Prior to the monitoring and evaluation study, the information collection instruments will be pilot-tested via telephone interview format, with a sample of 8 individuals who have requested these materials during the chosen study years. The surveys will include the following elements: (1) Use of the NGBTS materials, (2) Opinion of the NGBTS materials, (3) Respondent information on gender, present occupation and its duration, (4) Background information on the school or Organization/Community. Frequency of Response: This project will be conducted once. Affected Public: School personnel, and Community Leaders who have requested the NGBTS materials. Type of Respondent: School personnel, and Community Leaders who have requested the NGBTS materials from the NIDA site. Estimated Total Annual Number of Respondents: 400. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: .08. Estimated Total Annual Burden Hours Requested: 32.0. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

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: Phase II of A Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons. Type of Information Collection Request: New. Need and Use of Information Collection: The specific objectives of the current study are to: (1) Examine prospectively the relation between diet and major cancers (especially those of the breast, colorectal, prostate, and non- Hodgkin's lymphoma; (2) in a series of pilot studies, evaluate the quality and completeness of dietary data collected from automated web- based dietary assessment instruments, individually and collectively, in a large cohort, and; (3) in a calibration substudy, compare energy expenditure (measured by doubly labeled water) and protein and potassium intakes (measured by 24-hour urinary nitrogen and potassium excretion) with intakes of energy, protein, and potassium as reported on web-based, automated 24-Hour Dietary Record (24HR), an automated Diet History Questionnaire (DHQ), and an automated DHQ adjusted by automated 7-Day Food Lists (7DFLs) to assess measurement error structure in the instruments. The proposed study will build on the existing Prospective Study of Diet and Cancer in members of the American Association of Retired Persons by updating exposure information in the existing cohort and allowing for continued tracking and follow-up; (2) expanding the cohort by recruiting additional participants and surveying their diet and other exposures. In addition to the 566,403 persons from the original cohort, a new cohort of 2.5 million 50-59 year olds from the same states as the original AARP cohort, and 4 million 50-69 year olds from 8 new states will be contacted as part of the recruitment and data collection effort. Phase II will apply the latest technology to use web-based data collection instruments for economical and efficient assessment of dietary exposures of study participants. This uniquely designed cohort study has a capacity greater than that of any previous study for evaluating connections between dietary factors and major cancers. Frequency of Response: The frequency of response is dependent on the instrument and the portion of the study that the respondent is participating in (pilot, main study, and/or calibration substudy), as described in the table below. Affected Public: Individuals. Type of Respondents: U.S. adults (person ages 50-85). The annual reporting burden is as follows:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).

This notice announces the renewal and name change of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC). It also requests nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC).

This document corrects a technical error that appeared in the wage index table in the September 1, 2006 Federal Register, entitled ``Hospice Wage Index for Fiscal Year 2007.''

This notice with comment period describes the procedure for implementing Section 6053(b) of the Deficit Reduction Act of 2005, Public Law 109-171 for fiscal year 2008. Section 6053(b) of the Deficit Reduction Act provides for a modification of the Federal Medical Assistance Percentages for any state which has a significant number of evacuees from Hurricane Katrina.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included with this notice.

These proposed regulations implement provisions of title IV-D of the Social Security Act (the Act) as amended by the Deficit Reduction Act of 2005, Pub. L. 109-171 (DRA of 2005). The proposed regulations address use of the tax refund intercept program to collect past-due child support on behalf of children who are not minors, mandatory review and adjustment of child support orders for families receiving Temporary Assistance to Needy Families (TANF), reduction of Federal matching rate for laboratory costs incurred in determining paternity, States' option to pay more child support collections to former assistance families, and the mandatory annual $25 fee in certain child support (IV-D) cases in which the State has collected and disbursed at least $500 of support. The regulations also make other conforming changes necessary to implement changes to the distribution and disbursement requirements.

This notice provides an update of the HHS poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) and the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, HRSA, announces the establishment of the Advisory Council on Blood Stem Cell Transplantation by the Secretary, HHS. The Council will advise the Secretary on proposed C.W. Bill Young Cell Transplantation Program policies and other such matters as the Secretary determines. Duration of this Council is for two years unless renewed by the Secretary, HHS. This notice also requests nominations for membership on the Council.

The Administration for Children and Families (ACF) published a notice in the Federal Register of June 7, 2006 (Vol. 71, No. 109), pages 32969-32987, presenting the data measures, data composites, and national standards to be used in the Child and Family Services Review (CFSR). This notice provides corrections to this notice. A consolidated version of the June 7 Federal Register Announcement incorporating these corrections is provided on the Children's Bureau's Web site (address). The following are the key changes in the document and the reasons for the changes: There are new specifications for each of the individual measures included in each composite. After publication of the June 7, Federal Register Announcement, ACF conducted trainings on the CFSR data indicators at each of the 10 ACF Regional Offices. The trainings were provided to key administrators and staff of State child welfare agencies. During these trainings, issues were identified and questions were raised regarding the individual measures included in the composite. After reviewing these issues and questions, ACF determined that more specific information about the measures was needed and that some measures required revision in order to better target the outcome being assessed. The increased specification includes using the precise terminology that is used in the Adoption and Foster Care Analysis and Reporting System (AFCARS) and describing in greater detail the children who are in the denominator and numerator of each measure. The revisions to some of the measures required changes in the syntax used to calculate the measures. There is a new definition of foster parent used by the National Child Abuse and Neglect Data System (NCANDS). The change was made in this definition because the definition of a foster parent used by NCANDS was recently revised. There is a new version of the table of ranges, percentiles, and national standards for the data indicators and measures to be used in the second round of the Child and Family Services Review. This table replaces the Table 1 provided in the June 7, 2006 Federal Register. It was revised to reflect new data and new national standards for all of the CFSR data indicators. The data in the table and the national standards for all of the data indicators and measures are different than those presented in the June 7 Federal Register notice. This difference is due to one or both of the following reasons: (1) A change in the syntax for calculating some of the measures, and (2) a change in the process for calculating the national standards. The reason for the change in the procedures for calculating the national standards is provided in the following bullet. There are revisions and corrections to Attachment B: Methodology for Developing the Composites. The revisions in Attachment B were made to (1) correct an error in the original attachment B, (2) provide the new coefficients (weights) for the composite measures that resulted from the changes in the syntax, and (3) explain the new procedure for calculating the national standards. The error in the original attachment B occurred in Step 10 of the process of calculating the composite scores. The new coefficients (weights) for each of the measures included in the composites are presented in Table 1 of the attachmentCoefficients (Weights) for the Measures Included in the Permanency Related Data Composites. The coefficients/weights changed due to changes in the syntax used to calculate some of the individual measures. The new procedure for calculating the national standards involved changes in the statistical requirements for fitting the data to a normal curve and to changes in the parameters used in calculating the sampling error.

The Department of Health and Human Services (HHS) announces the establishment of a Physical Activity Guidelines Advisory Committee and is seeking nominations of qualified candidates to be considered for appointment as a member of the Committee.

This notice announces a public meeting on the subject of tuberculosis detection in imported nonhuman primates. The purpose of the meeting is to review current Institute of Laboratory Animal Research recommendations and compare newer diagnostic tests available for tuberculosis testing in nonhuman primates.

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-274-1998 ``Chromatographic Separation Apparatus and Method,'' U.S. Patent No. 6,379,973; HHS Ref. No. E-044-1993 ``Variable-Position Cross-Axis Synchronous Coil Plant Centrifuge for Countercurrent Chromatography;'' U.S. Patent 5,380,429; HHS Ref. No. E- 148-2001 ``Method and Apparatus for Countercurrent Chromatography;'' U.S. Patent Application No. 10/509,697 filed April 5, 2002; 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 instrumentation for countercurrent chromatographic purification of proteins and peptides.

This notice announces the 11th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations, and electronic submission using FDA Forms 3503 and 3504. This notice also notifies the public of, and solicits comments on, FDA's proposal to transfer the collection of information and burden associated with petitions submitted to amend the indirect food additive regulations from the subject collection of information Office of Management and Budget (OMB) control number 0910- 0016 to the collection of information for the Food Contact Substances Notification System (OMB control number 0910-0495).

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 Hanford Nuclear Reservation, Richland, Washington, 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: Hanford Nuclear Reservation. Location: Richland,Washington. Job Title and/or Job Duties: All former Dupont production workers in the 100 area and the 300 area and all 200 area production workers and all guards and construction workers. Period of Employment: January 1, 1943 through September 1, 1946 for former Dupont production workers in the 100 and 300 areas and December 1, 1944 through September 1, 1946 for all 200 area production workers and all guards and construction workers.

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, 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.

The Food and Drug Administration (FDA) is announcing a public meeting to explore opportunities to link private sector and public sector postmarket safety efforts to create a virtual, integrated, electronic ``Sentinel Network.'' Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. We are seeking input on a number of specific questions regarding opportunities for collaboration, the efficient use of information technology, and the collection and analysis of medical product safety information. Dates and Times: The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies'' dated December 2006. The draft guidance document provides recommendations that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood, for specified indications. The document also contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements.

The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Orthopaedic and Rehabilitation Devices Panel to deny a petition to reclassify the non-invasive bone growth stimulator from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by RS Medical Corp., as well as consideration of presentations made at the Panel meeting by the petitioner, FDA, and members of the public. FDA is also issuing for public comment its findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register.

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:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including Territories and Insular Areas). The purpose of these grants is to assist States in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2007.

The Food and Drug Administration (FDA, we) is publishing proposed recommendations for the reauthorization of the Prescription Drug User Fee program for the process of human drug application review for fiscal years (FY) 2008 to 2012. These proposed recommendations were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups. Section 505 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, enacted June 12, 2002, directs FDA to publish these proposed recommendations in the Federal Register; hold a meeting at which the public may present its views on such recommendations; and provide for a period of 30 days for the public to provide written comments on such recommendations.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Improving Quality of Care in Long Term Care.'' 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.

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.

Section 340B of the Public Health Service Act implements a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of proposed guidelines regarding contract pharmacy services that will allow covered entities to utilize contract pharmacy services arrangements previously limited to the Alternative Methods Demonstration Project program.

The Food and Drug Administration (FDA) is amending its food labeling regulations for the expanded use of the nutrient content claim ``lean'' on the labels of foods categorized as ``mixed dishes not measurable with a cup'' that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). This action is also being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.

The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.

The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

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: Jong Hyuk Park, Ph.D., University of Pittsburgh: Based on accumulated evidence including the University of Pittsburgh (UP) investigation committee report 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 Jong Hyuk Park, Ph.D., former postdoctoral fellow, Pittsburgh Development Center of the Magee-Womens Research Institute, UP, engaged in research misconduct in research funded by National Center for Research Resources (NCRR), National Institutes of Health (NIH), grant R24 RR13632 and National Institute of Child Health and Human Development (NICHD), NIH, grant P01 HD047675. Specifically, Dr. Park: (1) Intentionally and knowingly falsified various versions of two figures in a manuscript entitled ``Rhesus Embryonic Stem Cells Established by Nuclear Transfer: Tetraploid ESCs Differ from Fertilized Ones'' that was being prepared for submission to Nature; (2) Repeatedly misrepresented to the UP investigative panel the accuracy of one of the figures; (3) Presented the false figures as true to members of the laboratory; and (4) Falsified the record of revisions of the figures by deleting all prior versions from the laboratory server. ORI has implemented the following administrative actions for a period of three (3) years, beginning on November 29, 2006: (1) Dr. Park is debarred 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 defined in the debarment regulations at 45 CFR Part 76; and (2) Dr. Park is prohibited 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.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the FDA Medical Device Industry Coalition (FMDIC) and the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Medical Devices 101: An Educational Forum.'' This public workshop is intended to provide an overview on FDA's medical device requirements to entrepreneurs, startup companies, and small businesses. Date and Time: The public workshop will be held on February 9, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St. in Dallas, TX. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: oraswrsbr@fda.hhs.gov. Registration: Registration by January 26, 2007, is strongly encouraged. The RMSBDC has a $75 early registration fee to cover the cost of facilities, materials, and refreshments. Please submit your registration as soon as possible. Registration at the site may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration after January 26, 2007, is $99 payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 7 days in advance. Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214- 860-5849. The registration form is also available online at https:// www.ntsbdc.org/. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170).

The Food and Drug Administration (FDA) is extending to March 5, 2007, the comment period for the notice of public hearing that appeared in the Federal Register of October 25, 2006 (71 FR 62400). In the notice of public hearing, FDA requested comments on how the agency should regulate conventional foods marketed as ``functional foods'' under its existing legal authority. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.