Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Gene Therapy Clinical Trials-Observing Participants for Delayed Adverse Events; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005. The draft guidance provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in participants who have been exposed to gene therapy products. When finalized, this guidance will supplement the recommendations in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated October 2000, for study participant long-term followup. However, the recommendations in the Retroviral Vector guidance regarding the length of followup will be superseded by this Gene Therapy Clinical Trials guidance.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership that will become vacant on January 1, 2006.
Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2005 (70 FR 44660). The document announced the planning of a workshop as part of its Critical Path Initiative and requested comments. The document was published with an incorrect docket number. This document corrects that error.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
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 Phoenix Scientific, Inc. The supplemental ANADA provides for veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia.
Office of the Assistant Secretary for Planning and Evaluation (ASPE)-Area Poverty Research Centers
The Department of Health and Human Services published a document in the Federal Register of June 20, 2005 concerning a notice of funding availability to establish Area Poverty Research Centers. The document contained an incorrect date.
Public Meeting of the President's Council on Bioethics on September 8-9, 2005
The President's Council on Bioethics (Leon R. Kass, M.D., Chairman) will hold its twenty-first meeting, at which, among other things, it will continue its discussion of ethical issues relating to the treatment of the aged and the long-term care of patients with dementia. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), and Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005).
Strengthening HIV/AIDS Prevention, Care, and Treatment Referral Services to Targeting Populations Engaged in High-Risk Behavior 1
Provide a clear and concise summary of the proposed goals, major objectives and activities required to achieve the program goals and justify the amount of funding requested for the first budget year of this cooperative agreement. 2. Need. Describe Haiti's need for the services described in the activities section. Include any data on STI and HIV prevalence rates in Haiti. 3. Capacity. Describe the current capability and capacity of the organization to perform the activities described in this RFA. 4. Expansion. (a) Identify and secure appropriate (accessible and discreet) and suitable rental property for new confidential voluntary counseling and testing (VCT) clinics that are well equipped to deliver prevention, care and treatment services for MSM population. (b) Recruit and hire confidential VCT clinical personnel to provide a comprehensive HIV/AIDS service delivery facility addressing the needs of the target population. 5. Training. (a) Coordinate training to local health care Professionals, including physicians, nurses, laboratory and pharmacy technicians, and peer educators. This training will include: (1) Train how to design, implement and evaluate confidential VCT program sites. (2) Train how to maintain laboratory equipment. (3) Train in laboratory safety and proper disposal of bio-hazardous materials protocol. (4) Train in the use of universal precautions and the management of needle stick or splash injuries. (b) Provide regular routine in-service trainings for lab personnel to review new and best practice techniques, and to request ``insider insight,'' an account of implementation success and challenges, in the effort to identify gaps in resources or effectiveness of particular protocols. 6. Laboratory Capacity. 6.1. Provide basic laboratory services to support HIV/AIDS diagnosis and treatment. (a) Perform CD4 counts. (b) Perform complete blood counts. (c) Perform HIV rapid testing. (d) Perform confirmatory HIV/AIDS testing. (e) Test for sexually transmitted infections. (f) Provide pre- and post-test counseling for recipients of HIV test results. (g) Provide referrals to appropriate prevention, treatment, care and support services to HIV-infected patients. 7. Commodities. Procure drug and complementary commodities for service delivery programs. 8. Outreach. (a) Provide educational services in awareness, prevention and treatment of HIV/AIDS to high-risk populations of MSM. (1) Develop target population-specific messages and health promotion strategies to raise awareness about the new confidential VCT clinics. Peer educators may be used to accomplish this activity. (2) Develop specific interventions for sub-populations in the MSM community, including partner notification and support. (b) Gather data to establish baseline information regarding the target for first usage Haitian National Police (PNH) population's knowledge about HIV/AIDS transmission, as well as this population's sexual practices. (1) Assess attitudes and behaviors within the target PNH population. (2) Develop and implement long-term behavioral change communication campaigns. (3) Promote condom distribution and use. (4) Develop and implement behavior change strategies and long-term campaigns, including: a. Information, education and communication (IEC). b. Condom distribution. c. Targeted accessibility planning. 9. Management and Supervision. (a) Manage and supervise clinic operations and staff. (b) Implement report-writing requirements. (c) Develop and implement financial management systems. (d) Engage in strategic plan development. (e) Network with local partners within the private and public sector to ensure an effective patient referral system between confidential VCT services and antiretroviral treatment (ART) service delivery networks. 10. Monitoring and Evaluation. Implement M&E strategies. These strategies should assess the following performance indicators: (a) The number of people tested. (b) The number of people provided with treatment and services. (c) The segment of the target population served. (d) The number and type of testing performed. (e) The number of referrals made to appropriate prevention, treatment, care and support services. (f) The number of training courses held. (g) The number and type of participants in these training courses. (h) The number of trainee evaluations filed, and the findings of these evaluations. Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes: Budget Justification. Curriculum Vitas or resumes. Organizational Charts. Letters of Support. The budget justification will not count in the narrative page limit. You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-5711. For more information, please see the HHS/CDC Web site at: https:// www.cdc.gov/od/pgo/funding/grantmain.pdf. If your application form does not have a DUNS number field, please write the DUNS number at the top of the first page of the application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''
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