Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is providing notice of an amendment to memorandum of understanding (MOU) 222-09-0014 between the International Anesthesia Research Society (IARS) and FDA. The purpose of this MOU is to establish the framework for collaboration between the parties and to support their shared interest of promoting the safe use of anesthetics and sedatives in children. This is an amendment to this MOU to rename the SAFEKIDS (Safety of Key Inhaled and Intravenous Drugs in Pediatrics) Public-Private Partnership (PPP) to SmartTots (Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots) PPP.

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.

This notice announces our intention to sponsor a Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the second of three notices which must be published over a 90-day period in order to advise the public of the agency's intention to sponsor an FFRDC.

A proposal to certify Kluyveromyces lactis as a host-vector 1 system has been reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director. This decision is based upon the determination that the K. lactis host-vector 1 system affords a moderate degree of biological containment equal to other certified host-vector 1 systems presently listed in the NIH Guidelines. Moreover, it has been determined that certain research with this host-vector system does not present a significant risk to health and the environment and therefore will be exempt from the NIH Guidelines (See Section III-F-6 and Appendix C). Appendix C has been modified to indicate the nature of the research that is exempt when performed in a K. lactis certified host-vector 1 system. In addition, the Office of Biotechnology Activities is updating Appendix D of the NIH Guidelines to include additional lines of experimentation approved by the NIH Director; in this case an experiment involving the introduction of tetracycline resistance into Chlamydia trachomatis that falls under Section III-A-1-a of the NIH Guidelines.

The Health Resources and Services Administration, HIV/AIDS Bureau (HAB) Policy Notice 99-02 established policies for the use of Ryan White HIV/AIDS Program funds authorized under Title XXVI of the Public Health Service (PHS) Act, for housing referral services and short-term or emergency housing needs. Amendment 1 to Policy Notice 99-02, effective March 27, 2008, modified Policy Notice 99-02 by imposing a 24-month cumulative cap on short-term and emergency housing assistance. The limit on benefits would have taken effect on March 27, 2010, and would have impacted individuals who were users of the funds for housing assistance. HRSA received comments from the public concerning the potential impact of the cap and the threat to the ability of clients receiving Ryan White HIV/AIDS Program funded services to receive housing services. In response, HRSA's Administrator directed that Policy Notice 99-02 Amendment 1 be rescinded, as published in the February 10, 2010, Federal Register notice, Volume 75, Issue 27, pages 6672-6673. In addition, the notice indicated that HRSA was conducting a comprehensive review of the Housing Policy. As a result of a thorough vetting and comprehensive review, HRSA is issuing a final notice of Housing Policy Notice 11-01 which replaces HAB Policy Notice 99-02, effective May 12, 2011.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.

NIH is further extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) The adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by an additional 30 days and thus will end on May 24, 2011. Additionally, character limits on the comment form fields have been removed.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 25, 2010, page 52351 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 July 31, 2005, unless it displays a currently valid OMB control number. Proposed Collection: Title: Special Volunteer and Guest Researcher Assignment for use in NIH facilities. Type of Information Collection Request: Reinstatement, 0MB 0925-0177, Expiration Date July 31, 2005. Need and Use of Information Collection Request: Form Number: NIH-590. A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. Frequency of Response: once. Affected Public: Individuals. Type of Respondents: Non- federal scientific professionals and/or individuals. The annual Reporting burden is as follows: Estimated Number of Respondents: 1660; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.1; and Estimated Total Annual Burden Hours Requested: 166. The estimated annualized cost to respondents is $2,275. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Information From United States Firms and Processors That Export to the European Community'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017.

This proposed rule would set forth the hospice wage index for fiscal year 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This proposed rule would change the hospice aggregate cap calculation methodology. This proposed rule also would revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this proposed rule would begin implementation of a hospice quality reporting program.

In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a web meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The web meeting will be open to the public. Information about the Advisory Group can be obtained by accessing the following Web site: https:// www.healthcare.gov/center/councils/nphpphc/.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Y-12 Plant in Oak Ridge, TN, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Y-12 Plant. Location: Oak Ridge, TN. Job Titles and/or Job Duties: All workers potentially exposed to radioactive materials. Period of Employment: January 1, 1948 through December 31, 1957.

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 (the PRA).

This proposed rule would create a standardized, transparent process for States to follow as part of their broader efforts to ``assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area'' as required by section 1902(a)(30)(A) of the Social Security Act (the Act). This proposed rule would also recognize, as States have requested, electronic publication as an optional means of communicating State plan amendments (SPAs) proposed rate-setting policy changes to the public.

This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for discharges occurring during the rate year (RY) beginning July 1, 2011 through September 30, 2012. The final rule also changes the IPF prospective payment system (PPS) payment rate update period to a RY that coincides with a fiscal year (FY). In addition, the rule implements policy changes affecting the IPF PPS teaching adjustment. It also rebases and revises the Rehabilitation, Psychiatric, and Long-Term Care (RPL) market basket, and makes some clarifications and corrections to terminology and regulations text.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. These changes would be applicable to discharges occurring on or after October 1, 2011. We also are setting forth the proposed update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2011. We are proposing to update the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implement certain statutory changes made by the Affordable Care Act. These changes would be applicable to discharges occurring on or after October 1, 2011.

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.

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.

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/.

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.

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.

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:

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.

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.

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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at this time.