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

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Florida's Natural Growers, to market test a product designated as ``Frozen Concentrate for Lemonade 3+1 Ratio'' that deviates from the U.S. standard of identity for frozen concentrate for lemonade. The purpose of the temporary permit is to allow the applicant to measure customer acceptance of the product, identify mass production problems, and assess commercial feasibility.

The Food and Drug Administration (FDA) is announcing its determination that MINOCIN (minocycline hydrochloride) Capsules equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for minocycline hydrochloride capsules if all other legal and regulatory requirements are met.

This notice announces the continuation of effectiveness of a Medicare interim final and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if prior to the expiration of the timeline, the Secretary publishes in the Federal Register a notice of continuation and explains the exceptional circumstances justifying the extension of the timeline for publishing a final rule.

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.

This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution entitled, ``Making further continuing appropriations for the fiscal year 2008, and for all other purposes,'' Public Law 110-149 (``Continuing Resolution'') signed into law on December 21, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.

This proposed rule would revise and consolidate the criteria and processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs), designations that are used in a wide variety of Federal government programs. These revisions are intended to improve the way underserved areas and populations are designated, by incorporating up-to-date measures of health status and access barriers, eliminating inconsistencies and duplication of effort between the two existing processes. These revisions are intended to reduce the effort and data burden on States and communities by simplifying and automating the designation process as much as possible while maximizing the use of technology. No changes are proposed at this time with respect to the criteria for designating dental and mental health HPSAs. Podiatric, vision care, pharmacy, and veterinary care HPSAs, which are no longer in use, would be abolished under the rules proposed below. Additional background information will be available for review on the web site of the Health Resources and Services Administration: https://bhpr.hrsa.gov/shortage. The methodology is also described in a journal article recently published in the Journal of Health Care for the Poor and Underserved entitled ``Designating Places and Populations as Medically Underserved: A Proposal for a New Approach'' (Ricketts et al, 2007).

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Pediatric Advisory Committee notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on June 30, 2008, effective with this notice.

The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 entitled, The Use of Ryan White HIV/AIDS Program Funds for Housing Referral Services and Short-term or Emergency Housing Needs, provides grantees with guidance on the use of Title XXVI of the Public Health Service Act (Ryan White HIV/AIDS Program) funds for short-term and emergency housing assistance for persons living with HIV/AIDS. This Federal Register notice seeks to make public the final policy notice 99-02 Amendment 1 which places a cumulative period of 24 months on short-term and emergency housing assistance under the Ryan White HIV/AIDS Program, and clarifies and updates certain nomenclature found in the original housing policy 99-02. This policy becomes effective March 27, 2008.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), 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: Brain Power! The NIDA Junior Scientist Program, for grades K-5, and the companion program for Middle School, the Brain Power! Challenge. Type of Information Collection Request: This information collection request is for an EXTENSION of 0925-0542 that was obtained in 2005, and is requested for two additional years to meet scheduling availability for participating school districts. Need and Use of Information Collection: This is a request to evaluate the effectiveness of the Brain Power! Program's ability to (1) increase children's knowledge about the biology of the brain and the neurobiology of drug addiction, (2) increase positive attitudes toward science, careers in science, science as an enjoyable endeavor, and the use of animals in research; and stimulate interest in scientific careers; and (3) engender more realistic perceptions of scientists as being from many races, ages, and genders. The secondary goals of the evaluation are to determine the Program's impact on attitudes and intentions toward drug use. The findings will provide valuable information concerning the goals of NIDA's Science Education Program of increasing scientific literacy and stimulating interest in scientific careers. In order to test the effectiveness of the evaluation, information will be collected from students before and after exposure to the curriculum with pre- and post-test self-report measures. Surveys will also be administered to teachers after the completion of the program to examine ease and fidelity of implementation, as well as impact in knowledge and understanding of the neurobiology of addiction. Surveys will be administered to parents to obtain parental reaction and opinion on the materials and the degree to which parents find the curriculum informative and appropriate. Frequency of Response: On occasion. Affected Public: Elementary and middle school students, teachers, and parents. Type of Respondents: Students, Teachers, and Parents. The reporting burden is as follows: Estimated Number of Respondents: 1,337; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: .25; Estimated Total Annual Burden Hours Requested: 640.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

This proposed rule would implement two provisions of the Trafficking Victims Protection Act (TVPA) (22 U.S.C. Chapter 78), as amended by the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2003 (Pub. L. 108-193), that provide limitations on the use of funds. The provisions at Title 22 of the U.S.C. 7110(g) prohibit programs from using trafficking funds to promote, support, or advocate the legalization or practice of prostitution. They make ineligible to receive funds any organization that promotes, supports, or advocates the legalization or the practice of prostitution if the organization operates a program that targets victims of severe forms of trafficking, unless the organization provides assistance to individuals solely after they are no longer engaged in activities that resulted from their being trafficked. This proposed rule applies to funds that Congress appropriates for the U.S. Department of Health and Human Services for anti-trafficking purposes under Title 22 of the United States Code.

The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta- glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of CHD'' to include barley betafiber as another eligible source of beta-glucan soluble fiber.

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.

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:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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/.

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 https://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, https://www.noracoordinator@cdc.gov, (202) 245- 0665.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow information collection related to implementation of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization Certification and Related Forms and a Patient Safety Confidentiality Complaint Form.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Agency for Healthcare Research and Quality (AHRQ) invites individuals and organizations to nominate primary and secondary prevention topics pertaining to clinical preventive services that they would like the United States Preventive Services Task Force (USPSTF) to consider for review. All topics previously reviewed by the USPSTF are available on AHRQ's Web site, https://www.preventiveservices.ahrq.gov. The USPSTF is an independent panel of experts that makes evidence- based recommendations regarding the provision of clinical preventive services. Clinical preventive services include screening, counseling and preventive medications associated with primary care. The USPSTF makes recommendations about preventive services for asymptomatic peoplepeople without recognized signs or symptoms of the specific conditions targeted by the preventive service. Topics can be nominated by individuals, organizations, evidence- based practice centers (EPC) and USPSTF members. The USPSTF will consider nominations in two steps. The USPSTF will first determine if the service is eligible, i.e., constitutes primary or secondary prevention applicable to healthy asymptomatic persons; is primary care feasible or referable from primary care; and addresses a condition with a substantial health burden. As a second step, within eligible topics, the USPSTF will prioritize based on the following set of criteria: public health importance (burden of suffering, potential of preventive service to reduce the burden); and potential for greatest Task Force impact (e.g., clinical controversy, practice does not reflect evidence, inappropriate timing in delivery of services).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC). The purpose of this MOU is to establish a procedure to allow CDC/DSAT to confirm that FDA has accepted or approved, under the authority of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), an Investigational New Drug application (IND), a request to establish an Investigational New Animal Drug file (INAD), or an Investigational Device Exemption application (IDE) for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.

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 requirements relating to FDA's adverse experience reporting (AER) for licensed biological products, and general records associated with the manufacture and distribution of biological products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Testing of Drug Metabolites.'' This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. It also provides recommendations on the timing and type of nonclinical studies that should be conducted to investigate the potential for clinical toxicity of drug metabolites. This guidance applies to small molecule nonbiologic drug products under development. This guidance finalizes the draft guidance published on June 6, 2005.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of January 11, 2008 (73 FR 2055). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. There are no other changes.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Quality through Health IT: Testing the Feasibility and Assessing the Impact of Using Existing Health IT Infrastructure for Better Care Delivery.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is amending certain regulations regarding generally recognized as safe (GRAS) substances to remove references to FDA development of food-grade specifications in cooperation with the National Academy of Sciences (NAS, now the National Academies). This action is editorial in nature and is intended to ensure the accuracy of the agency's regulations.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-second meeting, at which it will discuss and hear presentations on (1) newborn screening and (2) the problems of cost, access, and quality in American health care. The Council will also unveil its most recent publication, Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics. Subjects discussed at past Council meetings (although not on the agenda for the March 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan-extension. 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), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports on (a) controversies in the determination of death, and (b) organ procurement, transplantation, and allocation are forthcoming.

Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (HHS) seeks a Cooperative Research and Development Agreement (CRADA) and/or license(s) with a pharmaceutical or biotechnology company to develop and commercialize amphipathic helical peptides potentially useful for the treatment and prevention of cardiovascular disease. The CRADA would have an expected duration of one (1) to five (5) years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, methods of treatment or prevention that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA defined by the CRADA Research Plan, subject to any pre-existing licenses already issued for other fields of use, and can apply for background licenses to the existing patent applications encompassed within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use.

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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the Emergency Preparedness and Response Research Portfolio. The document and instructions for submitting comments can be found at https:// www.cdc.gov/niosh/review/public/126/. Comments may be given orally at the following meeting, as well as provided to the NIOSH Docket Office. Public Meeting Time and Date: 8:30 a.m.-5 p.m., March 25, 2008. Place: Hyatt Regency Crystal City, 2799 Jefferson Davis HWY, Arlington, Virginia 22202. Purpose of Meeting: NIOSH has developed strategic goals to address important issues surrounding the health and safety of emergency responders. The full list of goals can be accessed through the NIOSH Web site at: https://www.cdc.gov/niosh/programs/epr/goals.html. The eight overarching goals are: 1. SAFETY CLIMATE: Improve the organization of emergency response work to reduce exposure to risks and to enhance the health and safety of emergency responders. 2. PERSONAL PROTECTIVE EQUIPMENT (PPE): Improve PPE assortment, proper selection and wear, and decontamination. 3. ENGINEERING/TECHNOLOGICAL INTERVENTIONS AND CONTROLS: Improve engineering controls, technology, and tools to minimize responders' exposures to hazards associated with chemical, biological, radiation or nuclear (CBRN), toxic industrial compound (TIC), and other hazardous materials. 4. CHARACTERIZATION/ASSESSMENT OF POTENTIAL HAZARDS: Develop methods to evaluate the spatial and temporal distribution of gases, vapors, and aerosols, as well as liquids or particulates associated with surface contamination. 5. SUBGROUP-SPECIFIC STRATEGIES: Improve subgroup awareness, develop targeted messages, and expand subgroup-preferred channels. 6. SURVEILLANCE: Develop surveillance reporting systems to improve emergency responder safety and health through the systematic collection, analysis, and interpretation of exposure, hazard, injury, and illness data. 7. ENVIRONMENTAL MICROBIOLOGY: Improve the understanding of environmental microbiology of threat agents, including environmental factors that influence the introduction, spread, and control of these agents. 8. ENVIRONMENTAL AND BIOLOGICAL MONITORING OF TERRORISM AGENTS: Improve the identification and characterization of terror agents to reduce exposures to response and remediation workers. Stakeholders are encouraged to review the strategic goals on the NIOSH Web site (https://www.cdc.gov/niosh/programs/epr/goals.html ) in order to prepare their comments/feedback around the following topics to be discussed. Written responses can be submitted in person at the meeting or by emailing nioshdocket@cdc.gov. Please reference Docket Number NIOSH-126 in your response. Give your opinion about the top three goals needed to improve the safety and health of emergency responders. Discuss why these are the top goals. Address any obstacles in achieving these goals. Talk about how research can help the nation address the top goals that you have identified. Provide a couple of examples of research ideas for each of your top goals identified. Discuss opportunities you see on the horizon that could lead to improvements in emergency responder safety and health. Please include as much information as might be useful for understanding the safety or health research priority you identify. Such information could include characterization of the frequency and severity with which the injury, illness, or hazardous exposure is occurring and of the factors you believe might be causing the health or safety issue. Input is also requested on the types of research that you believe might make a difference and which partners (e.g., specific industry associations, labor organizations, research organizations, government agencies) should be involved in informing research efforts and solutions. Status: The public meeting is open to everyone, including all workers, professional societies, organized labor, employers, researchers, health professionals, government officials, and elected officials. The public meeting will address priorities for emergency preparedness and response research during both morning and afternoon public comment periods. Participants are invited to speak for 5 minutes about the discussion topics listed above. Participants may register to speak during either the morning or afternoon session, though they are encouraged to stay for both sessions. Broad participation is desired. All participants are requested to register for the free meeting by e-mailing nioshdocket@cdc.gov or on site the day of the meeting, space permitting. Participants wishing to speak are encouraged to register early. This meeting is open to the public, limited only by the space available. Background: The mission of the NIOSH Emergency Preparedness and Response (EPR) Program portfolio is to advance research and collaborations to protect the health and safety of emergency response providers and recovery workers by preventing diseases, injuries, and fatalities in anticipation of and during responses to natural and man- made disasters and novel emergent events. The EPR Program research portfolio cuts across the eight sectors that are the focus of the National Occupational Research Agenda (NORA). NORA is a partnership program to stimulate innovative research and improved workplace practices. Unveiled in 1996, NORA has become a research framework for NIOSH and the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Public Comment Period: Those unable to attend the public meeting may submit input to the NIOSH Docket Office within 60 days after the date of publication of this notice in the Federal Register. Reference NIOSH Docket 126 in comments. Contact Person for Technical Information: Dr. Renee Funk, EPR Portfolio Coordinator at (404) 498-2499 or e-mail rfunk@cdc.gov. Comments may be e-mailed to nioshdocket@cdc.gov or sent via postal mail to: Centers for Disease Control and Prevention, NIOSH Docket-126, Robert A. Taft Laboratories (C-34), 4676 Columbia Parkway, Cincinnati, OH 45226. Additional Information: A limited number of rooms have been reserved in the same hotel as the meeting for participants who require lodging for the night of March 24th. Please contact the hotel reservations desk for rooms under ``NIOSH Town Hall Meeting'' by the March 3rd deadline at (703) 418-7233. Reference: More information about NIOSH/EPR can be found on the NIOSH Web page at: https://www.cdc.gov/niosh/programs/epr/.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for ketamine hydrochloride injectable solution from Veterinary Research Associates, Inc., to Putney, Inc.

This notice announces the 24th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 16th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 24th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed ``patient safety work product'' by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.

The U.S. Department of Health and Human Services (HHS) announces the final in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. This meeting will be open to the public. The Physical Activity Guidelines Advisory Committee has been charged with reviewing existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. The Committee's recommendations will be utilized by the Department to prepare the final Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.