Department of Health and Human Services September 8, 2008 – Federal Register Recent Federal Regulation Documents

Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
Document Number: E8-20779
Type: Rule
Date: 2008-09-08
Agency: Department of Health and Human Services, Food and Drug Administration
The Food and Drug Administration (FDA) is removing its regulation that established restrictions on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. We are removing the restrictions because we believe they are no longer needed to prevent the further introduction, transmission, or spread of monkeypox, a communicable and potentially fatal disease, in the United States.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Document Number: E8-20778
Type: Notice
Date: 2008-09-08
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 Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 26, 2008, (Vol. 73 No. 124, page 36337) 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 September 24, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's Recommendation on Listing Status for Styrene in the 12th RoC and the Scientific Justification for the Recommendation
Document Number: E8-20777
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
The RoC Office invites public comment on the recommendation from an expert panel on the listing status for styrene in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for styrene is available electronically in Part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682, see Expert Panel Report Part B) or in printed text from the RoC Office (see FOR FURTHER INFORMATION CONTACT below). The RoC Office convened an eleven-member expert panel of scientists from the public and private sectors on July 21-22, 2008. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for styrene in the 12th RoC and (2) to provide the scientific justification for the recommendation.
FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop
Document Number: E8-20730
Type: Notice
Date: 2008-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates(SoCRA), is announcing a workshop on FDA Clinical Trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, November 19, 2008, from 8 a.m. to 5 p.m. and Thursday, November 20, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Westin Crown Center, 1 East Pershing Rd., Kansas City, MO 64118, 816-474-4400, FAX: 816-391-4438. Contact: David Arvelo, Food and Drug Administration, 4040 N. Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: david.arvelo@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $575 (member), $650 (nonmember), $525 (government employee nonmember), or $450 (government employee member). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, 530 West Butler Ave., suite 109, Chalfont, PA 18914. To register via the Internet go to https://www.socra.org/html/FDA_Conference.htm (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Westin Crown Center at the reduced conference rate, contact the Westin Crown Center (see Location) before October 21, 2008. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited; therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact David Arvelo (see Contact) at least 21 days in advance of the workshop.
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: E8-20709
Type: Rule
Date: 2008-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: E8-20681
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
Document Number: E8-20675
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services
This notice announces the meeting date for the 24th 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). Meeting Date: September 23, 2008, from 8:30 a.m. to 3 p.m. (Eastern).
Government-Owned Inventions; Availability for Licensing
Document Number: E8-20651
Type: Notice
Date: 2008-09-08
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: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV
Document Number: E8-20650
Type: Notice
Date: 2008-09-08
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 worldwide exclusive license to practice the invention embodied in:
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-20647
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-20646
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-20644
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; the National Diabetes Education Program Comprehensive Evaluation Plan
Document Number: E8-20636
Type: Notice
Date: 2008-09-08
Agency: Department of Health and Human Services, National Institutes of Health
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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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: The National Diabetes Education Program Comprehensive Evaluation Plan. Type of Information Collection Request: Extension of a currently approved collection (0925-0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to: Improve the treatment and health outcomes of people with diabetes, promote early diagnosis, and, ultimately, prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families and the public. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759, Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital, Operating or Maintenance Costs to report.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.