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

Guidance for Industry: Chemistry, Manufacturing, and Control Changes to an Approved New Animal Drug Application or Abbreviated New Animal Drug Application
Document Number: E7-10515
Type: Notice
Date: 2007-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (83) entitled ``Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA.'' This guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report certain changes to such applications, in accordance with the final regulation, 21 CFR 514.8, which was issued in the Federal Register of December 13, 2006 (71 FR 74766).
Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products
Document Number: E7-10492
Type: Notice
Date: 2007-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that describes a new process for making available recommendations on how to design product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the first group of draft product-specific BE recommendations.
Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
Document Number: E7-10491
Type: Notice
Date: 2007-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
This notice announces the availability of draft guidances for industry that describe recommendations on how to design bioequivalence (BE) studies for 200 specific drug products to support abbreviated new drug applications (ANDAs). These draft guidances are being made available concurrently with the publication of a draft guidance for industry entitled ``Draft Guidance for IndustryBioequivalence Recommendations for Specific Products'' (product specific BE recommendations). This draft guidance describes the new process for making available guidance on product-specific BE studies. Under the process described in the draft guidance, draft and final product-specific BE study guidance will be made available on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a related guidance document entitled ``Draft Guidance for Industry Bioequivalence Recommendations for Specific Products.''
Office of the Director, Office of Translational Research; Availability of Report From Global Environmental Health Workshop: Request for Public Comments
Document Number: E7-10479
Type: Notice
Date: 2007-05-31
Agency: Department of Health and Human Services, National Institute of Environmental Health Sciences, National Institutes of Health
The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease. NIEHS has prioritized Global Environmental Health (GEH) as a major initiative of its new strategic plan to implement its vision. To obtain advice and guidance on potential research strategies for global environmental health, the NIEHS held the Global Environmental Health Workshop on January 10, 2007, and now invites public comments on the workshop report.
Prospective Grant of Co-Exclusive License: Developing, Manufacturing and Selling Instruments, Reagents and Related Products and Providing Services Involving Sequencing Nucleic Acids, Including Without Limitations Diagnostic Devices and Services
Document Number: E7-10478
Type: Notice
Date: 2007-05-31
Agency: Department of Health and Human Services, National Institutes of Health
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. 60/151,580, filed August 29, 1999; PCT/US00/23736, filed August 29, 2000, U.S. 6,982,146 issued January 3, 2006, and USSN 11/204,367, filed August 12, 2005; entitled ``High Speed Parallel Molecular Nucleic Acid Sequencing'', to Invitrogen Corporation having a place of business in Carlsbad, California. The patent rights in this invention have been assigned to the United States of America.
Submission for OMB Review; Comment Request; The Jackson Heart Study (JHS)
Document Number: 07-2698
Type: Notice
Date: 2007-05-31
Agency: Department of Health and Human Services, National Institutes of Health
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 for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on October 25, 2006, pages 62476-62477, 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. 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 currently valid OMB control number. Proposed Collection: Title: The Jackson Heart Study (JHS). Type of Information Collection Request: Extension of a currently approved collection (OMB NO. 0925-0491). Need and Use of Information Collection: This project involves annual follow-up by telephone of participants in the JHS, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in African American men and women. Frequency of Response: One time. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; Businesses or other for profit; not-for-profit institutions. The annual reporting burden is as follows: Estimated Number of Respondents: 600; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.5 and Estimated Total Annual Burden Hours Requested: 300. The annualized cost to respondents is estimated at $9,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Notice of Meeting
Document Number: 07-2688
Type: Notice
Date: 2007-05-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Agency for Healthcare Research and Quality Contract Review Meeting
Document Number: 07-2681
Type: Notice
Date: 2007-05-31
Agency: Department of Health and Human Services, Agency for Healthcare Research and Quality
Prospective Grant of Exclusive License: Proteomics in Cancer Diagnostics and Therapy
Document Number: E7-10354
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
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), a federal agency under the 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-261-1998 ``Methods and Devices for Isolation and Analysis of Cellular Protein Content;'' U.S. Patent 6,969,614; and E-039-2003/0 ``Combinatorial Therapy for Protein Signaling Diseases,'' U.S. Patent Application No. 10/798,799 filed March 10, 2004; to Theranostics Health, LLC, a Limited Liability Company formed under the laws of the state of Delaware and having a principle place of business in Rockville, Maryland. The United States of America is the assignee of the patent rights in the above inventions. The contemplated exclusive license may be granted a field limited to proteomic diagnostics for cancer requiring regulatory approval.
Prospective Grant of Exclusive License: Use of Cripto-1 as Claimed in the Licensed Patent Rights, for the Development of a FDA Approved Diagnostic Kit for Human Cancers
Document Number: E7-10352
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 7,078,176; European Patent No. 1370869 and PCT Application No. PCT/US02/02225 and foreign equivalents thereof entitled ``Detection and quantification of Cripto-1'' (E-290-2000/0), to Biosite, Inc, which is located in San Diego, California. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights, for the development of a FDA approved diagnostic kit for human cancers.
Prospective Grant of Exclusive License: Development of Anti-HIV Therapeutics, Anti-HIV Topical Microbicides, and Anti-Breast Cancer Therapeutics
Document Number: E7-10334
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
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 license to practice the invention embodied in: PCT/US99/13856 filed June 18, 1999, preceded by U.S. Provisional Patent Application Serial No. 60/089,842 (HHS Ref. E-136-1998/0-US-01), filed June 19, 1999, entered the national stage filing in June 1999 in Korea Patent Application No. 10-2000-7014479; in Mexico Patent Application No. 012525; in Australia Patent Application No. 46972/99; in Canada Patent Application No. 2335464; in Brazil Patent Application No. PI9911385-6; in U.S. Patent No. 6,706,729 and filed DIV in U.S. Patent Application No. 10/738,062 in December 2003; in EPO Patent Application No. 99930428.0 and validated in Germany, France, United Kingdom, Italy and Ireland in November 2006, entitled ``Novel Thioesters and Uses Thereof'', Inventors: Drs. James A. Turpin (NCI), Yongsheng Song (NCI), John K. Inman (NIAID), Mingjun Huang (NCI), Anders Wallqvist (NCI), Andrew Maynard (NCI), David G. Covell (NCI), William G. Rice (NCI), and Ettore Appella (NCI); PCT/US02/23924 filed July 25, 2002, preceded by U.S. Provisional Patent Application Serial No. 60/310,133 (E-329-2000/0-US-01), filed August 3, 2001, entered the national stage filing in February 2004 in EPO Patent Application No. 02756732.0; in Australia Patent Application No. 2003322721; in Canada Patent Application No. 2456083 and U.S. Patent Application No. 10/485,165, entitled ``Acylthiols and Component Thiol Compositions as Anti-HIV and Anti-Retroviral Agents'', Inventors: Drs. John K. Inman (NIAID), Atul Goel (NCI), Ettore Appella (NCI), and Jim A. Turpin (NCI);
Government-Owned Inventions; Availability for Licensing
Document Number: E7-10332
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Cancer Institute; Proposed Collection; Comment Requested; Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan
Document Number: E7-10331
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3507(a)(1)(D) 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 of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 18, 2007, pages 2286-2287 and allowed 60-days for public comment. No public comments were received. 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 currently valid OMB control number.
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 07-2683
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
Document Number: 07-2679
Type: Notice
Date: 2007-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled, ``Interim Melamine and Melamine Analogues Safety/Risk Assessment.'' The interim safety/risk assessment describes the risk to human health associated with eating pork, chicken, fish, and eggs from animals that were inadvertently fed animal feed that contained melamine and its analogues (cyanuric acid, ammelide and ammeline). FDA is seeking public comment on the interim safety/risk assessment to assist the agency and the Food Safety and Inspection Service (FSIS) at the U. S. Department of Agriculture (USDA) in the ongoing investigation of contaminated vegetable protein products imported from China that were mislabeled as ``wheat gluten'' and ``rice protein concentrate,'' and ensuring the safety of the U.S. food supply.
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 07-2673
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 07-2672
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 07-2671
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-2670
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 07-2669
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 07-2668
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 07-2667
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 07-2666
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 07-2665
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 07-2664
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Amended Notice of Meeting
Document Number: 07-2663
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Meeting
Document Number: 07-2662
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 07-2661
Type: Notice
Date: 2007-05-30
Agency: Department of Health and Human Services, National Institutes of Health
HIPAA Administrative Simplification: National Plan and Provider Enumeration System Data Dissemination
Document Number: 07-2651
Type: Notice
Date: 2007-05-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice establishes the data that are available from the National Plan and Provider Enumeration System (NPPES). In addition, this notice addresses who may have access to the data or may receive data from the system, the processes for requesting and receiving data, and the conditions under which data may be disclosed.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
Document Number: E7-10271
Type: Notice
Date: 2007-05-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E7-10267
Type: Notice
Date: 2007-05-29
Agency: Food and Drug Administration, Department of Health and Human Services
Timed-Release Drug Products Containing Guaifenesin; Enforcement Action Dates
Document Number: E7-10266
Type: Notice
Date: 2007-05-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products. Hundreds of unapproved drug products in timed-release form containing guaifenesin, alone or in combination with other ingredients, are marketed to relieve the symptoms associated with cough, cold, and similar conditions. Such drug products require approved applications because they are not generally recognized as safe and effective for these uses. One firm has obtained approved applications to market timed-release products containing guaifenesin. Other firms who wish to market a drug product in timed-release form containing guaifenesin must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Centers for Disease Control and Prevention
Document Number: E7-10219
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention
The NIOSH National Personal Protective Technology Laboratory (NPPTL) will hold a public meeting to discuss a proposed Total Inward Leakage (TIL) program for half-mask air-purifying particulate filtering respirator certification with plans to later include similar requirements for all respirator certifications.
Task Force on Community Preventive Services
Document Number: E7-10217
Type: Notice
Date: 2007-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicaid Program; Cost Limit for Providers Operated by Units of Government and Provisions To Ensure the Integrity of Federal-State Financial Partnership
Document Number: 07-2657
Type: Rule
Date: 2007-05-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This regulation clarifies that entities involved in the financing of the non-Federal share of Medicaid payments must be a unit of government; clarifies the documentation required to support a Medicaid certified public expenditure; limits Medicaid reimbursement for health care providers that are operated by units of government to an amount that does not exceed the health care provider's cost of providing services to Medicaid individuals; requires all health care providers to receive and retain the full amount of total computable payments for services furnished under the approved Medicaid State plan; and makes conforming changes to provisions governing the State Child Health Insurance Program (SCHIP) to make the same requirements applicable, with the exception of the cost limit on reimbursement. The Medicaid cost limit provision of this regulation does not apply to: Stand-alone SCHIP program payments made to governmentally-operated health care providers; Indian Health Service (IHS) facilities and tribal 638 facilities that are paid at the all-inclusive IHS rate; Medicaid Managed Care Organizations (MCOs), Prepaid Inpatient Health Plans (PIHPs), and Prepaid Ambulatory Health Plans (PAHPs); Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs). Moreover, disproportionate share hospital (DSH) payments and payments authorized under Section 701(d) and Section 705 of the Benefits Improvement Protection Act of 2000 are not subject to the newly established Medicaid cost limit for governmentally-operated health care providers. Except as noted above, all Medicaid payments and SCHIP payments made under the authority of the State plan and under waiver and demonstration authorities, as well as associated State Medicaid and SCHIP financing arrangements, are subject to all provisions of this regulation. Finally, this regulation solicits comments from the public on issues related to the definition of the Unit of Government.
Proposed Information Collection Activity; Comment Request
Document Number: 07-2628
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Center for Scientific Review; Amended Notice of Meeting
Document Number: 07-2626
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 07-2625
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 07-2624
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-2623
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-2622
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 07-2621
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 07-2620
Type: Notice
Date: 2007-05-29
Agency: Department of Health and Human Services, National Institutes of Health