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

Results 51 - 100 of 285
Combe, Inc.; Filing of Color Additive Petition
Document Number: E8-3416
Type: Notice
Date: 2008-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Combe, Inc., has filed a petition proposing that the color additive regulations be amended to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
Document Number: E8-3415
Type: Notice
Date: 2008-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
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 guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-820
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 08-819
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 08-818
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 08-817
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 08-816
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 08-815
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 08-814
Type: Notice
Date: 2008-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-3321
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: E8-3294
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-3274
Type: Notice
Date: 2008-02-22
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.
Office of Intramural Training and Education; Undergraduate Scholarship Program; Submission for OMB Review; Comment Request; National Institutes of Health Undergraduate Scholarship Program for Individuals From Disadvantaged Backgrounds
Document Number: E8-3273
Type: Notice
Date: 2008-02-22
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, the Office of Loan Repayment and Scholarship, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 6, 2007 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. Proposed Collection: Title: National Institutes of Health Undergraduate Scholarship Program for Individuals From Disadvantaged Backgrounds (UGSP). Type of Information Collection Request: Extension of a previously approved collection (OMB No. 0925-0438, expiration date December 31, 2007Extended to February 29, 2008). Form Numbers: NIH 2762-1, NIH 2762-2, NIH 2762-3, NIH 2762-4, and NIH 2762-5. Need and Use of Information Collection: The NIH makes available scholarship awards to students from disadvantaged backgrounds that are committed to careers in biomedical research. The scholarships pay for tuition and reasonable educational and living expenses up to $20,000 per academic year at an accredited undergraduate institution. In return, for each year of scholarship support, the recipient is obligated to serve as a full-time paid employee in an NIH research laboratory for 10 consecutive weeks during the months of June through August and for 1 year after graduation. If the recipient is enrolled in an undergraduate program or pursues a postgraduate degree (doctoral, medical, dental, or veterinarian school), the post-graduation service obligation may be deferred with the approval of the Secretary, Department of Health and Human Services. The information proposed for collection will be used by the Office of Intramural Training and Education to determine an applicant's eligibility for participation in the UGSP and a participant's eligibility to defer his or her service obligation. The UGSP is authorized by section 487D of the Public Health Service (PHS) Act (42 U.S.C. 288-2), as amended by the NIH Revitalization Act of 1993 (Pub. L. 103-43). Frequency of Response: Initial application and annual renewal application. Affected Public: Applicants (high school or undergraduate students), recommenders, undergraduate institution financial aid staff, participants wishing to defer their service obligation, and graduate or undergraduate registrar staff. The annual reporting burden estimates are as follows:
Medicaid Program; Premiums and Cost Sharing
Document Number: E8-3211
Type: Proposed Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement and interpret the provisions of sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005 (DRA), and section 405(a)(1) of the Tax Relief and Health Care Act of 2006 (TRHCA). These sections amend the Social Security Act (the Act) by adding a new section 1916A to provide State Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. This authority is in addition to the existing authority States have to impose premiums and cost sharing under section 1916 of the Act. The DRA provisions also specifically address cost sharing for non-preferred drugs and non-emergency care furnished in a hospital emergency department.
Medicaid Program; Health Care-Related Taxes
Document Number: E8-3207
Type: Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the collection threshold under the regulatory indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006. When determining whether there is an indirect guarantee under the 2-prong test for portions of fiscal years beginning on or after January 1, 2008 and before October 1, 2011, the allowable amount that can be collected from a health care-related tax is reduced from 6 to 5.5 percent of net patient revenues received by the taxpayers. This final rule also clarifies the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test (with conforming changes to parallel provisions concerning hold harmless arrangements with respect to provider-related donations); codifies changes to permissible class of health care items or services related to managed care organizations as enacted by the Deficit Reduction Act of 2005; and, removes obsolete transition period regulatory language.
Medicaid Program; State Flexibility for Medicaid Benefit Packages
Document Number: E8-3206
Type: Proposed Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of section 6044 of the Deficit Reduction Act of 2005, Pub. L. 109-171, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. Under this new section, States have increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients.
Medicare Program; Medicare Secondary Payer (MSP) Amendments
Document Number: E8-2938
Type: Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On February 24, 2006, we published an interim final rule with comment period in the Federal Register that implemented amendments to the Medicare Secondary Payer (MSP) provisions under Title III of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA clarified the MSP provisions regarding the obligations of primary plans and primary payers, the nature of the insurance arrangements subject to the MSP rules, the circumstances under which Medicare may make conditional payments, and the obligations of primary payers to reimburse Medicare. In this final rule, we are finalizing several clarifications made to the MSP provisions. In addition, we are responding to public comments on the February 24, 2006 interim final rule with comment period that pertain to these MSP provisions.
Medicare Program; Public Meetings in Calendar Year 2008 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
Document Number: E8-2837
Type: Notice
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2008 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Medicare Program; Prior Determination for Certain Items and Services
Document Number: E8-2811
Type: Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This final rule establishes reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained. This rule also responds to public comments on the August 30, 2005 proposed rule.
Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups
Document Number: E8-2806
Type: Notice
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice solicits the nominations of three individuals for consideration as members on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). There will be three vacancies on the Panel: One vacancy as of June 1 and two additional vacancies as of September 30, 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS), and the Administrator of the Centers for Medicare & Medicaid Services (CMS), concerning the clinical integrity of the APC groups and their associated weights. We consider the Panel's advice as we prepare the annual updates of the Medicare hospital outpatient prospective payment system (OPPS). The Secretary rechartered the Panel in 2006 for a 2-year period effective through November 21, 2008. Submission Date of Nominations: Nominations will be considered if postmarked by 5 p.m. E.S.T. on April 1, 2008, and sent to the designated address provided in the ADDRESSES section of this notice.
Medicare Program: Approval of Application by the Indian Health Service (IHS) for Continued Recognition as a National Accreditation Organization That Accredits American Indian and Alaska Native (AI/AN) Entities To Furnish Outpatient Diabetes Self-Management Training
Document Number: E8-2803
Type: Notice
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces the approval of the Indian Health Service (IHS) as a national accreditation organization for the purpose of determining that entities meet the necessary quality standards to furnish outpatient diabetes self-management training services under Part B of the Medicare program. Therefore, American Indian and Alaska Native diabetes self-management training (DSMT) programs accredited by the IHS will receive deemed status under the Medicare program for purposes of this benefit.
Medicare Program; Extension of Certain Hospital Wage Index Reclassifications
Document Number: E8-2798
Type: Notice
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the extension of the expiration date for certain wage index geographic reclassifications and special exceptions as implemented by section 117 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (Pub. L. 110-173). Certain geographic reclassifications and special exception hospitals' wage indices that were set to expire on September 30, 2007 are now extended through September 30, 2008. In addition, for hospital reclassifications extended by Division B, Title I, section 106(a) of the Tax Relief and Health Care Act of 2006, Pub. L. 109-432, that resulted in a lower wage index for the second half of FY 2007, we will apply the higher wage index that was applicable to such hospitals during the first half of FY 2007, for the entire fiscal year.
Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education; March 11, 2008
Document Number: E8-2790
Type: Notice
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 08-824
Type: Notice
Date: 2008-02-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 08-796
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Cancer Institute; Notice of Meeting
Document Number: 08-795
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
Document Number: 08-794
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services, National Cancer Institute; Notice of Closed Meeting, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 08-792
Type: Notice
Date: 2008-02-22
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: 08-791
Type: Notice
Date: 2008-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates, the Hospital Inpatient Prospective Payment System and FY 2008 Payment Rates; and Payments for Graduate Medical Education for Affiliated Teaching Hospitals in Certain Emergency Situations Medicare and Medicaid Programs: Hospital Conditions of Participation; Necessary Provider Designations of Critical Access Hospitals; Correction
Document Number: 08-671
Type: Rule
Date: 2008-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register (FR) on November 27, 2007, entitled ``Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates, the Hospital Inpatient Prospective Payment System and FY 2008 Payment Rates; and Payments for Graduate Medical Education for Affiliated Teaching Hospitals in Certain Emergency Situations Medicare and Medicaid Programs: Hospital Conditions of Participation; Necessary Provider Designations of Critical Access Hospitals.''
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: E8-3267
Type: Notice
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the agency) is publishing proposed recommendations for the reauthorization of the Animal Drug User Fee Act of 2003 (ADUFA) for fiscal years (FY) 2009 to 2013. These proposed recommendations were developed after a public meeting with stakeholders and discussions with regulated industry. ADUFA, enacted November 18, 2003, 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 a period of 30 days for the public to provide written comments on such recommendations. Dates and Time: The public meeting will be held on March 11, 2008, from 1 p.m. to 3:30 p.m. Location: The public meeting will be held at 7519 Standish Pl., third floor, rm. A, Rockville, MD 20855. There is parking near the building. Photo identification is required to clear building security. Contact Person: Roxanne Schweitzer, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240-276-9705, FAX: 240-276-9744, e-mail: Roxanne.Schweitzer@fda.hhs.gov. Registration: To ensure there is sufficient room we ask that you pre-register. Furthermore, to assist us in scheduling, we ask that you notify us through the registration process if you wish to make a public comment at the meeting. To register, please send an electronic mail message to roxanne.schweitzer@fda.hhs.gov by March 4, 2008. Your e-mail should include the following information: Name, Company, Company Address, Company Telephone Number, and E-mail Address. You will receive a confirmation within 2 business days. FDA also will accept walk-in registration at the meeting site, but space is limited, and the agency will close registration when maximum seating capacity (approximately 500) is reached. FDA will try to accommodate all persons who wish to make a public comment at the meeting, including those who register at the meeting site, however, the time allotted for public comments may depend on the number of persons who wish to speak. Additionally, please notify FDA (see Contact Person) if you need any special accommodations (such as wheelchair access or a sign language interpreter) at least 7 days in advance. Comments: To ensure consideration of your comments regarding these proposed recommendations, you should submit comments by April 14, 2008. Interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government- wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only.
Oral Dosage Form New Animal Drugs; Ivermectin Liquid
Document Number: E8-3266
Type: Rule
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides revised labeling for ivermectin oral liquid used in horses.
Oral Dosage Form New Animal Drugs; Altrenogest
Document Number: E8-3265
Type: Rule
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 Intervet, Inc. The supplemental NADA provides for revised food safety labeling for altrenogest oral solution used in horses.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability
Document Number: E8-3187
Type: Notice
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Availability
Document Number: E8-3186
Type: Notice
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic- specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.
Submission for OMB Review; Comment Request; Process Evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP)
Document Number: E8-3166
Type: Notice
Date: 2008-02-21
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 Fogarty International Center (FIC), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 30, 2007, 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. Proposed Collection: Title: Process evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP). Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the outputs of the Global Health Research Initiative Program for New Foreign Investigators (GRIP) to date, assess the program's alignment with new strategic goals of the FIC, and identify potential directions for program enhancement. The primary objectives of the study are to determine if GRIP awards (1) promote productive re-entry of NIH-trained foreign investigators into their home countries, (2) increase the research capacity of the international scientists and institutions, and (3) stimulate research on a wide variety of high priority health-related issues. The findings will provide valuable information concerning: (1) Specific research advances attributable to GRIP support; (2) specific capacity and career enhancing advances that are attributable to GRIP; (3) policy implications for GRIP at the program level based on survey responses, such as successes and challenges of the program's implementation, the GRIP support mechanism, etc. Frequency of Response: Once. Affected Public: None. Type of Respondents: Foreign researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 101; Estimated Number of Responses Per Respondent: 1; Average Burden Hours Per Response: 0.50; and Estimated Total Annual Burden Hours Requested: 50.5. The annualized cost to respondents is estimated at: $656.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table 1 and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.
Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer
Document Number: E8-3165
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 09/693,600 filed October 20, 2000 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002- 555834 filed October 22, 2001 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent Application No. 01989341.1 filed October 22, 2001 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to ODC Therapy, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for breast cancer patients expressing high levels of serum or plasma IgE.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-3164
Type: Notice
Date: 2008-02-21
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.
Prospective Grant of Exclusive License: Regulatory Approved Clinical Diagnostics for Anti-HPV16 L1 Serum Antibody Detection in HPV Vaccine Recipients
Document Number: E8-3162
Type: Notice
Date: 2008-02-21
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 worldwide license to practice the invention embodied in HHS Ref. No. E-253-1993/0 and certain foreign rights under HHS Ref. No. E-166-1992 including U.S. Patent 5,437,951, U.S. Patent 5,985,610, U.S. Patent 5,871,998, U.S. Patent 5,716,620, U.S. Patent 5,744,142, U.S. Patent 5,756,284, U.S. Patent 5,709,996, U.S. Patent Application 09/ 316,487, U.S. Patent Application 10/371,846, International Patent Application PCT/US93/08342, European Patent Application 93921353.4, European Patent Application 040104531.1, European Patent Application 040783235, Australian Patent 683220, Australian Patent Application 2004203609, Canadian Patent No. 2,143,845, Japanese Patent Applications 1994-507481, Japanese Patent Applications 2001-101791 and continuation and divisional patents and patent applications thereof, entitled ``Self-Assembling Recombinant Papillomavirus HPV16 Capsid Proteins,'' to Biotrin International, Ltd., a limited liability company formed under the laws of the European Union and the Republic of Ireland. The United States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of regulatory approved clinical diagnostics for serum anti-HPV16 L1 antibody detection in HPV vaccine recipients.
Proposed Information Collection Activity; Comment Request
Document Number: 08-777
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Office for Civil Rights: Audio Conference on Proposed Regulations Related to Patient Safety
Document Number: 08-776
Type: Notice
Date: 2008-02-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality Director Dr. Carolyn Clancy and Office for Civil Rights Deputy Director of Health Information Privacy Susan McAndrew will host a joint audio conference February 29, 2008 from 2-3 p.m. (Eastern Standard Time) to discuss the recently published proposed regulation regarding Patient Safety and Quality Improvement and statutory confidentiality protections. The purpose of this audio conference is to facilitate public understanding of the proposed regulation and rulemaking process outlined in the Notice of Proposed Rulemaking published in the Federal Register February 12, 2008. To register for the audio conference, log on to http:// www.academyhealth.org/ahrq/psoaudio/.
National Institute on Aging; Notice of Closed Meeting
Document Number: 08-774
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases, Notice of Closed Meeting
Document Number: 08-773
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 08-772
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 08-771
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: E8-3102
Type: Notice
Date: 2008-02-20
Agency: Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-3077
Type: Notice
Date: 2008-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-3076
Type: Notice
Date: 2008-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Public Meeting
Document Number: E8-3071
Type: Notice
Date: 2008-02-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 9 a.m.-3 p.m. EST, February 27, 2008. Place: Patriots Plaza, 395 E Street SW., Conference Room 9000, Washington, DC 20201. Purpose of Meeting: NORA has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now able to be structured as a public meeting via the Internet in order to attract participation by a larger number of organizations and to enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Councils on their progress, priorities and implementation plans to date, including the Agriculture, Forestry and Fishing Sector; Healthcare and Social Assistance Sector; Transportation, Warehousing and Utilities Sector; Mining Sector and Oil and Gas Extraction Sub-Sector. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an E-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact phone number on the day of the meeting, and preference for participation by web meeting (requirements include: Computer, internet connection and phone, preferably with ``mute'' capability) or in person. An E-mail confirming registration will include the details needed to participate in the web meeting. Non-U.S. citizens are encouraged to participate in the web meeting. Non-U.S. citizens registering to attend in person after February 15 will not have time to comply with security procedures. Background: The National Occupational Research Agenda (NORA) is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http://www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured by industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008, most of these Councils will post draft strategic plans for public comment. For more information, see the link above and choose ``Sector-based Approach,'' ``NORA Sector Councils'' and ``Comment on Draft Sector Agendas'' from the right-side menu. Contact Person for Technical Information: Sidney C. Soderholm, Ph.D., NORA Coordinator, http://www.noracoordinator@cdc.gov, (202) 245- 0665.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-3064
Type: Notice
Date: 2008-02-20
Agency: Department of Health and Human Services, Health Resources and Services Administration