Department of Health and Human Services February 21, 2008 – Federal Register Recent Federal Regulation Documents

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 https:// 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 https:// 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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.