Department of Health and Human Services May 2006 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 304
New Animal Drugs for Use in Animal Feeds; Melengestrol and Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and tylosin to make two-way combination Type C medicated feeds for heifers fed in confinement for slaughter.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Companion Document to Direct Final Rule
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. The regulation of other recovered blood vessels would remain unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed changes are noncontroversial, and we do not anticipate any significant adverse comments. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We are issuing these amendments directly as a final rule because they are noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2007: Annual Payment Rate Updates, Policy Changes, and Clarification
This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The payment amounts and factors used to determine the updated Federal rates that are described in this final rule have been determined for the LTCH PPS rate year July 1, 2006 through June 30, 2007. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and will continue to be effective each October 1. The outlier threshold for July 1, 2006, through June 30, 2007, is also derived from the LTCH PPS rate year calculations. We are also finalizing policy changes and making clarifications.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Drug Experience Reporting
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Drug Experience Reporting'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry; Process for Handling Pediatric Referrals to FDA: Additional Safeguards for Children in Clinical Investigations.'' This guidance is intended to assist clinical investigators, institutional review boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The draft guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under these regulations and in reaching final determinations in accordance with these regulations.
Food Safety and Defense Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas and the Mid-Continental Association of Food and Drug Officials, is announcing a public workshop entitled ``Food Safety and Defense Workshop.'' This public workshop is intended to provide information about current Good Manufacturing Practice regulations for foods, Hazard Analysis Critical Control Point (HACCP), food defense awareness, and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on June 6 and 7, 2006, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Continuing Education Center in Fayetteville, AR, located downtown (2 East Center St.). Accommodations: There are many lodging choices in the area, but the Radisson Hotel in Fayetteville (479-442-5555) is immediately adjacent to the Continuing Education Center. Contact: Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu. You may also contact David Arvelo, Food and Drug Administration, 4040 N Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: david.arvelo@fda.hhs.gov. Registration: Registration by May 28, 2006, is encouraged. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Please submit your registration as soon as possible. Those accepted into the course will receive confirmation. Registration at the site is not guaranteed, but may be possible on a space-available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200, payable to ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the form available online at https://www.mcafdo.org/ or the registration form in this document and submit along with a check or money order for $150 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Government-Owned Inventions; Availability for Licensing
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: The Development of C-6 and C-8 Modified cAMP-Derivatives for the Treatment of Cancer
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 07/198,489 filed May 23, 1988, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E- 132-1988/0-US-01], PCT Application filed May 19, 1989 [HHS Reference No. E-132-1988/0-PCT-02], U.S. Patent Application No. 07/896,452 filed June 4, 1992, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-132-1988/0-US-04], U.S. Patent 5,792,752 filed October 27, 1994 and issued August 11, 1998, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-132-1988/0-US-05], U.S. Patent 5,902,794 filed September 22, 1997 and issued May 11, 1999, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-132-1988/ 0-US-06] and Canadian Patent Application No. 133572 filed May 19, 1989, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E- 132-1988/0-CA-03], to Kuhnil Pharm. Co. Ltd., which has offices in Seoul, Republic of Korea. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of cancer with 8-Cl- cAMP.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2006 (RY 2007)
This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the rate year beginning July 1, 2006 through June 30, 2007. In addition, we are adopting the new Office of Management and Budget (OMB) labor market area definitions for the purpose of geographic classification and the wage index. We are also making revisions to existing policies and implementing new polices.
Announcement of Availability of Funds for One Family Planning General Training and Technical Assistance Grant in Public Health Service Region VI
The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Tuesday, April 11, 2006, announcing the availability of funds for one family planning general training and technical assistance grant. This notice contained an error. Language related to the review and selection process was not included. This Notice corrects the omission of the language related to collaborative selection of a grantee by the Regional Health Administrator, the Director, Office of Family Planning, and the Deputy Assistant Secretary for Population Affairs.
Amendment of February 4, 2004, Order To Embargo Birds and Bird Products Imported From Gaza, the West Bank, and the Ivory Coast (Co
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/[H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 Federal Register 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; Burkina Faso on April 10, 2006; and Pakistan on April 10, 2006. On April 11, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Gaza. On April 25, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in the Ivory Coast (Cote d'Ivoire). At this time, HHS/CDC is adding Gaza, the West Bank, and the Ivory Coast (Cote d'Ivoire) to its current embargo. CDC is including the West Bank in its determination because the administrative regions of Gaza and the West Bank are the same with respect to animal movement and trade. USDA has also taken a similar action with respect to this region. This action is effective on April 28, 2006, and will remain in effect until further notice.
Request for Applications for Two Programs for FY 2006: Prevention for HIV Infected Women Living in Puerto Rico; and HIV Prevention for Women Living in the U.S. Virgin Islands
This program is authorized by 42 U.S.C. 300u-2(a). The Office on Women's Health (OWH), Office of Public Health and Science (OPHS) is the focal point for women's health within the Department of Health and Human Services (DHHS). Under the direction of the Deputy Assistant Secretary for Women's Health, OWH provides leadership to promote health equity for women and girls through gender- specific approaches. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These include supporting collaborative efforts to provide prevention education to infected women as well as women at risk for infection living in the U.S. and its territories. The emphasis of these efforts is on education and prevention counseling, including the ABC \1\ Abstinence, Being Faithful, Condoms model, covering the full spectrum of primary and secondary prevention adapted to a female centered perspective. In addition, efforts to establish enrichment support activities for women living with HIV are a primary emphasis as well. This initiative is intended to demonstrate a collaborative partnership approach between the grantee and local health or social service providers, e.g., community health centers, rural health centers, family planning clinics, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), tribal governments and organizations, Indian Health Service providers, community based organizations, faith based organizations, public assistance programs, and local health departments.
Office of Community Services; Program Announcement for Assets for Independence Program Grants
On February 9, 2005, the Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Demonstration Program. This program provides grant support for Individual Development Account (IDA) projects administered by government agencies and non-profit organizations. This Notice amends the final Fiscal Year (FY) 2006 application due date. This Notice announces a change in the final FY 2006 application due date from June 15, 2006 to July 18, 2006. This Notice also announces two conference call series. The first series will provide an overview of the Assets for Independence Demonstration Program, including application procedures and requirements. The second series will provide an orientation to administering effective Individual Development Account (IDA) projects with support from the Assets for Independence Demonstration Program. The Program Announcement for the Assets for Independence Demonstration Program is a standing announcement. It is effective until canceled or changed by the Office of Community Services (OCS). Applicants may submit applications at any time throughout the year. (Any changes to application due dates in successive years will be announced through publication of a Notice in the Federal Register, on the ACF Grant Opportunities Web page at https://www.acf. hhs.gov/grants/ index.html, and on https://www.Grants.gov.) OCS will review and make funding decisions about applications in three separate funding cycles annually. For FY 2006, the due dates are: November 1, 2005; March 15, 2006; and July 18, 2006. For example, starting in mid-March, OCS reviews all applications submitted November 2 through March 15. Starting in mid- July, OCS reviews all applications submitted March 16 through July 18. And, starting in early November, OCS reviews all applications submitted July 19 through November 1. Unsuccessful applicants may submit a new application in any succeeding application period. (1) Under the Executive Summary section of the original Program Announcement, please delete the following: The Administration for Children and Families, Office of Community Services (OCS) will accept applications for financial assistance to establish and administer Assets for Independence (AFI) Projects. These projects assist low-income people in becoming economically self- sufficient. They do so by teaching project participants about economic and consumer issues and enabling them to establish matched savings accounts called Individual Development Accounts (IDA) in order to save for a first home, a business, or higher education. Grantees must participate in an on going national evaluation of the impact of AFI Projects and IDAs. This is a standing announcement. It is effective until canceled or changed by the Office of Community Services. Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applicants submitted by any of three due dates: March 15, June 15 and November 1. (If a date falls on a weekend, the due date will be the following Monday.) For example, starting in mid- March annually, OCS will review all applications submitted November 2 through March 15. Starting in early June, OCS will review all applications submitted March 16 through June 15. And, starting in early November, OCS will review all applications submitted June 16 through November 1. Unsuccessful applicants may submit a new application in any succeeding application period. Please replace the deleted paragraphs under the Executive Summary section of the original Program Announcement with the following: The Administration for Children and Families (ACF), Office of Community Services (OCS) will accept applications for financial assistance to establish and administer Assets for Independence (AFI) Projects. These projects assist people with low incomes to become economically self-sufficient. They do so by teaching project participants about economic and consumer issues and enabling them to establish matched savings accounts called Individual Development Accounts (IDA) in order to save for a first home, a business, or higher education. Grantees must participate in an on going national evaluation of the impact of AFI Projects and IDAs. This is a standing announcement. It is effective until canceled or changed by the Office of Community Services. Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applicants submitted by any of three due dates in FY 2006: November 1, 2005; March 15, 2006; and July 18, 2006. Unsuccessful applicants may submit a new application in any succeeding application cycle. (2) Under Priority Area 1, Section I. Funding Opportunity Description of the original Program Announcement please delete the following: The Administration for Children and Families, Office of Community Services (OCS) will accept applications for financial assistance to establish and administer Assets for Independence (AFI) Projects. These projects assist low-income people in becoming economically self- sufficient. They do so by teaching project participants about economic and consumer issues and enabling them to establish matched savings accounts called Individual Development Accounts (IDA) in order to save for a first home, a business or higher education. Grantees must participate in an ongoing national evaluation of the impact of AFI Projects and IDAs. This is a standing announcement. It is effective until canceled or changed by the Office of Community Services. Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applicants submitted by any of three due dates: March 15, June 15, and November 1. (If a date falls on a weekend, the due date will be the following Monday.) For example, starting in mid- March annually, OCS will review all applications submitted November 2 through March 15. Starting in early June, OCS will review all applications submitted March 16 through June 15. And, starting in early November, OCS will review all applications submitted June 16 through November 1. Unsuccessful applicants may submit a new application in any succeeding application period. Please replace the deleted paragraphs under Priority Area 1, Section I. Funding Opportunity Description with the following: The Administration for Children and Families (ACF), Office of Community Services (OCS) will accept applications for financial assistance to establish and administer Assets for Independence (AFI) Projects. These projects assist people with low incomes to become economically self-sufficient. They do so by teaching project participants about economic and consumer issues and enabling them to establish matched savings accounts called Individual Development Accounts (IDA) in order to save for a first home, a business, or higher education. Grantees must participate in an on going national evaluation of the impact of AFI Projects and IDAs. This is a standing announcement. It is effective until canceled or changed by the Office of Community Services. Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applicants submitted by any of three due dates in FY 2006: November 1, 2005; March 15, 2006; and July 18, 2006. Unsuccessful applicants may submit a new application in any succeeding application cycle. (3) Please insert the following in Section VIII. Other: The Office of Community Services announces Two Informational Conference Call Series: The Office of Community Services, through its Assets for Independence Resource Center, will sponsor a series of Overview Conference Calls featuring general information about the program and the application requirements and procedures. These calls will be held on May 9, May 16, and May 23, 2006 at 2-3:30 p.m., eastern daylight time. The Resource Center will also host a series of Orientation Conference Calls with information and tips on administering effective Individual Development Account projects supported by the Assets for Independence Demonstration Program. These calls are scheduled for May 11, May 17, May 18, May 25, June 1, June 7 and June 8, 2006. Each of the calls will be held from 2-3:30 p.m., eastern daylight time. The Resource Center may also schedule additional calls. Please go to the OCS Asset Building Web site at https://www. acf.hhs.gov/asset building for a schedule of calls and other details. The Web site also includes dial-in numbers and pre-registration information. Participants are strongly encouraged to pre-register, as the number of lines is limited. The Resource Center will provide background information to all individuals who pre-register. All information in this Notice of amendment is accurate and replaces information specified in the February 9, 2005 Notice, the Notice of correction published on June 10, 2005, and the notice of amendment published on November 17, 2005. Announcement Availability: The Assets for Independence Demonstration Program announcement and all application materials are available at https://www.Grants.gov. Standard forms and certifications may also be found at https://www. acf.hhs.gov/programs/ ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/ assetbuilding provides extensive information about the Assets for Independence Demonstration Program and the application process. The page includes links to all required forms, a guidebook for developing an AFI Project, and information on applying for an AFI grant.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
42 U.S.C. 299c, section 931 of the Public Health Service (PHS Act), established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to actions of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Eight current members' terms will expire in November 2006. To fill these positions in accordance with the legislative mandate establishing the Council, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) In the fields of health care quality research or health care improvement; (3) In the practice of medicine; (4) In other health professions; (5) In representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) In the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) In representing the interests of patients and consumers of health care. Individuals are particularly sought with experience and success in activities specified in the summary above.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
