Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 363
Meeting of the President's Council on Fitness, Sports, and Nutrition; Correction
The Department of Health and Human Services published a notice in the Federal Register of April 21, 2011 to announce a meeting of the President's Council on Fitness, Sports, and Nutrition that will be held on May 10, 2011, from 11 a.m. to 2:30 p.m., in the U.S. Capitol Visitor Center, East Capitol and First Streets, NE., Washington, DC 20001. The meeting location has changed.
Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products.'' This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug products packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, or spoons). FDA is issuing this guidance because of ongoing concerns about potentially serious accidental drug overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or incompatible with the labeled dosage directions for orally ingested OTC liquid drug products.
Information Required in Prior Notice of Imported Food
The Food and Drug Administration (FDA) is amending its regulations on prior notice of imported food. As required by the FDA Food Safety Modernization Act, FDA is issuing this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of imported food into the United States.
Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption
The Food and Drug Administration (FDA) is amending its regulations on administrative detention of food for human or animal consumption. As required by the FDA Food Safety Modernization Act (FSMA), FDA is issuing this interim final rule to change the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Partnerships To Advance the National Occupational Research Agenda (NORA)
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: 10 a.m.-3:30 p.m. EDT, June 29, 2011. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of the Meeting: The National Occupational Research Agenda (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 structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further 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 NORA Sector Councils on their progress, priorities, and implementation plans to date, including the NORA Manufacturing, Public Safety, Services, and Wholesale and Retail Trade Sector Councils. Updates will also be given on the Mid- Decade Review of NORA, the NORA Symposium 2011, and at least one NIOSH Program that is working on several NORA priorities, e.g., the NIOSH Economics Program. 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 telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: Computer, Internet connection, and telephone, 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 who do not register to attend in person on or before June 6, 2011, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. Background: 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 http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008-10, most of these Councils posted draft strategic plans for public comment and eight have posted finalized National Sector Agendas after considering comments on the drafts. For the National Sector Agendas, see https://www.cdc.gov/niosh/nora/.
Public Health Information Network (PHIN) Messaging Guide for Syndromic Surveillance
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is requesting public comment on the draft PHIN Messaging Guide for Syndromic Surveillance. The document translates the business requirement recommendations from the International Society for Disease Surveillance to technical specifications to support meaningful use of electronic health records for syndromic surveillance. Comments will be used to inform and finalize the Messaging Guide.
Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging
This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). The final rule will implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. This final rule will remove this undue hardship and financial burden.
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on October 8, 2010. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created four (4) workgroups or subcommittees to analyze the areas of clinical quality, clinical operations, implementation, and privacy and security. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or subcommittee to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) A timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a subcommittee report, the HIT Standards Committee will: (1) Accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) Assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://healthit.hhs.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT
The Food and Drug Administration (FDA) has determined the regulatory review period for VOTRIENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Listing of Color Additives Exempt From Certification; Reactive Blue 69
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of disodium 1-amino-4- [[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,1 0-dihydro- 9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-3), also known as Reactive Blue 69, as a color additive in contact lenses. This action is in response to a petition filed by Sauflon Pharmaceuticals Ltd.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment
The Food and Drug Administration (FDA) is announcing the reestablishment of the Medical Imaging Drugs Advisory Committee in the Division of Advisory Committee and Consultants Management, Center for Drug Evaluation and Research.
2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference
The Food and Drug Administration (FDA), in cosponsorship with the Parenteral Drug Association (PDA), is announcing a public conference entitled ``PDA/FDA Glass Quality ConferenceBest Practices to Prevent and/or Detect At-Risk Glass Packaging.'' Date and Time: The public conference will be held on May 23, 2011, from 7 a.m. to 6:30 p.m. and May 24, 2011, from 7 a.m. to 4:30 p.m. Location: The public conference will be held at the Key Bridge Marriott Hotel, 1401 Lee Highway, Arlington, VA 22209, 1-703-524-6400, FAX: 1-703-524-8964. Contact Person: Wanda Neal, Parenteral Drug Association (PDA), PDA Global Headquarters, Bethesda Towers, 4350 East-West Highway, suite 200, Bethesda, MD 20814, 1-301-656-5900, extension 111, FAX: 1-301-986- 1093, e-mail: neal@pda.org. Accommodations: Attendees are responsible for their own accommodations. To make reservations at the Key Bridge Marriott Hotel, at the reduced conference rate, contact the Key Bridge Marriott Hotel (see Location), citing meeting code ``PDA.'' Room Rates are: Single/ Double: $229, plus applicable state and local. Reservations can be made on a space and rate availability basis. Registration: You are encouraged to register at your earliest convenience. The PDA registration fees cover the cost of facilities, materials, and breaks. Seats are limited; therefore, submit your registration as soon as possible. Conference space will be filled in order of receipt of registration. Onsite registration will be available on a space available basis on the day of the public conference beginning at 7 a.m. on May 23, 2011. The cost of registration is as follows:
Medicare & Medicaid Programs; Influenza Vaccination Standard for Certain Participating Providers and Suppliers
This proposed rule would require certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless the patient or patient's representative or surrogate declined vaccination. This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rates from influenza. This proposed rule would also require certain providers and suppliers to develop policies and procedures that would allow them to offer vaccinations for pandemic influenza, in case of a future pandemic influenza event for which a vaccine may be developed.
Request for Input To Inform a Possible Surgeon General Action on Prescription Drug Abuse in Youth
The National Institute on Drug Abuse, a Research Institute of the National Institutes of Health, is seeking on behalf of the Department of Health and Human Services information for an anticipated Surgeon General response to the public health problem of prescription drug abuse among youth.
Submission for OMB Review; Comment Request; Cancer Biomedical Informatics Grid® (caBIG®) Support Service Provider (SSP) Program (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 February 11, 2011 (76 FR 7867) 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: cancer Biomedical Informatics Grid [supreg] (caBIG [supreg]) Support Service Provider (SSP) Program (NCI). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The NCI Center for Biomedical Informatics and Information Technology (CBIIT) launched the enterprise phase of the caBIG [supreg] initiative in early 2007 with an emphasis on widespread institutional adoption of the program and tools. This emphasis on adoption has generated an expanding community with diverse needs for support, which are met through the resources available through the caBIG [supreg] Enterprise Support Network (ESN), including the caBIG [supreg] Support Service Provider (SSP) Program. The caBIG [supreg] SSPs provide caBIG [supreg] end-users with the freedom to match what caBIG [supreg] has to offer to their unique organizational goals and needs, so having this customized support option available is critically important to advancing the goals of the caBIG [supreg] program. caBIG [supreg] SSP applicants are evaluated against well-defined criteria published in the SSP Program Announcement and must successfully demonstrate that they have the technical capabilities, staffing and scalability, geographic coverage (when applicable), and the domain expertise in biomedicine to effectively serve caBIG [supreg] users. The information submitted by SSP applicants enables NCI to determine whether such applicants are qualified to enter into trademark license negotiations with NCI to use the caBIG [supreg] trademarks in connection with their services and become designated as caBIG [supreg] SSPs. Thus, the collection of information from SSP applicants is critical to both ensuring that the goals and objectives of the caBIG [supreg] program will be maintained and furthered by the organizations designated as SSPs and facilitating NCI's ability to exercise appropriate stewardship of the caBIG [supreg] trademarks. Sections 410 and 411 of the Public Health Service Act (42 U.S.C. 285 and 285a) authorize the collection of the information. Frequency of Response: once for the applicants. caBIG [supreg] SSP applications are accepted on a rolling basis and reviewed several times a year. Affected Public: Private sector including Business or other for-profits and not- for-profit organizations and institutions. Type of Respondents: Technical representatives of commercial, academic or not-for-profit organizations. The annual reporting burden is estimated at 360 hours. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
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 under the Paperwork Reduction Act of 1995.
Reimbursement Rates for Calendar Year 2011
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2011 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
