Department of Health and Human Services July 2007 – Federal Register Recent Federal Regulation Documents

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 Elanco Animal Health. The supplemental NADA revises the indications for use of two-way combination Type B and Type C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate.

This notice announces the 11th 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.).

The Office of Public Health and Science (OPHS) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services. Management support for the activities of this Committee are the responsibility of the OPHS. The qualified individuals will be nominated to the Secretary of the Department of Health and Human Services for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for overlapping four-year terms.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Los Alamos National Laboratory, Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 22, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the W.R. Grace site, Erwin, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 22, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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.

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.

This interim final rule with comment period will amend our regulations regarding grants to States for operation of qualified high risk pools to conform to provisions of the Deficit Reduction Act of 2005 and the State High Risk Pool Funding Extension Act of 2006. Those provisions extended funding for seed and operational grants for State High Risk Pools and amended section 2745 of the Public Health Service Act.

This document amends the interim final regulation that implements the Mental Health Parity Act of 1996 (MHPA) to conform the sunset date of the regulation to the sunset date of the statute under legislation passed on December 9, 2006.

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement the act. These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Emergency Use Authorization of Medical Products.'' The guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. This guidance finalizes the draft guidance published in the Federal Register of July 5, 2005 (70 FR 38689).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007. The draft guidance document discusses certain cell selection devices that minimally manipulate autologous PBSCs at the point of care for specific clinical indications, and the applicability of the requirements to such PBSCs. The guidance also discusses the submission of data intended to support approval of cell selection devices.

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.

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 Institute of Child Health and Human Development (NICHD), 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: NICHD Research Partner Satisfaction Surveys. Type of Information Collection Request: RENEWAL of OMB Clearance 0925-0532. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the National Institute of Child Health and Human Development (NICHD), Office of Science Policy, Analysis and Communication (OSPAC), seeks to obtain OMB's generic approval to conduct customer satisfaction surveys surrounding its research programs and activities. The NICHD was founded in 1963. Its mission is to ensure, through research, the birth of healthy infants and the opportunity for each to reach full potential in adulthood, unimpaired by physical or mental disabilities. The NICHD conducts and supports research on the many factors that protect and enhance the processes of human growth and development. The developmental focus of the NICHD means that its research portfolio is unusually broad. NICHD programs include research on infant mortality, birth defects, learning disorders, developmental disabilities, vaccine development, and demographic and behavioral sciences, among others. In addition to supporting laboratory research, clinical trials, and epidemiological studies that explore health processes, the NICHD disseminates information that emanates from its research programs to its customers, or those who are partners with the Institute. This includes scientists, practitioners, other health professionals, and the public. Survey information will augment the NICHD's on-going efforts to assess their research funding mechanisms, activities, and programs, as well as the information products that are used to disseminate research findings. Primary objectives are: (1) To identify opportunities and barriers to achieving scientific aims; (2) to learn about emerging scientific opportunities and unmet public health needs; (3) to measure customer satisfaction with information products; and (4) to identify strengths and weaknesses of the NICHD's program operations. The OSPAC will use the survey results to better respond to its customers, including its various partners in research, and to improve the NICHD's research programs and activities. Findings will help to: (1) Formulate strategies to help enhance research opportunities and remove barriers; (2) target the NICHD's research programs and activities to take advantage of emerging scientific opportunities and meet public health needs related to its mission; (3) develop information products tailored to the NICHD audience; and (4) improve program planning, management, and operations. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Members of the public; eligible grant applicants and actual applicants (both successful and unsuccessful); clinicians and other health professionals; and actual or potential clinical trials participants. The annual reporting burden is as follows: Estimated Number of Respondents: 28,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: Varies with survey type, see below; and Estimated Total Annual Burden Hours Requested: 5,883. The annualized cost to respondents is estimated at: $109,541.46. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 Office of Extramural Research, 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: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 9/30/07. Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. Need and Use of Information Collection: The application is used by applicants to request Federal assistance for research and research-related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or Households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 158,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 15.8; and Estimated Total Annual Burden Hours Requested: 2,517,466. The estimated annualized cost to respondents is $88,058,547. 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 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.

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 provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States.

Section 6034 of the Deficit Reduction Act of 2005 established the Medicaid Integrity Program to promote the integrity of the Medicaid program by authorizing the Centers for Medicare and Medicaid Services (CMS) to enter into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would set forth limitations on a contractor's liability while performing these services under the Medicaid Integrity Program. This proposed rule would provide for limitation of a contractor's liability for actions taken to carry out a contract under the Medicaid Integrity Program. The proposed rule would, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Atlanta District and Southeast Regional Office (SER), in collaboration with Georgia Food Safety and Defense Task Force, and the Metro Environmental Health Directors Food Service Advisory Committee, is announcing a public workshop entitled ``Food Safety and Defense . . . Be ALERT!'' This public workshop will provide information about how to control foodborne illness risk factors and how to secure food from intentional contamination (food defense awareness). The target audience will be operators of small, independent (non-chain) retail and food service establishments. Date and Time: This public workshop will be held on Wednesday, August 15, 2007, from 9 a.m. to 3 p.m. Location: The public workshop will be held at the Hilton Atlanta Northeast Hotel, 5993 Peachtree Industrial Blvd., Norcross, GA. Contact: JoAnn Pittman, Food and Drug Administration, Atlanta District, Southeast Region, 60 8th St., NE., Atlanta, GA 30309, 404- 253-1272, FAX: 404-253-1202, or e-mail: JoAnn.Pittman@fda.hhs.gov. Registration is at no charge: The registration deadline is August 1, 2007; please see instructions in this document. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but, may be possible on a space available basis (100 maximum) on the day of the public workshop beginning at 9 a.m. If you need special accommodations due to a disability, please contact JoAnn Pittman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the registration form in this document and submit to `` Food and Drug Administration, Attn: Dan Redditt, 60 8th St., NE.. Atlanta, GA 30309.'' We encourage you to fax the completed registration form to: 404-253-2257 or 404-253-1202. To obtain a copy of the registration form, please contact: Dan Redditt at 404-253-1265 or via e-mail at joseph.redditt@fda.hhs.gov.

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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pulse Oximeters Premarket Notification Submissions [510(k)s].'' The draft guidance describes FDA's recommendations about the content of premarket notification submissions (510(k)s) for pulse oximeter devices.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Trans Fat Claims on Foods'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.'' This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH).

The Food and Drug Administration (FDA) is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met.

This final rule with comment period will implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid Program. The DRA requires the Secretary of HHS to promulgate a final regulation no later than July 1, 2007. In addition, we are adding to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule will bring together existing and new regulatory requirements in one, cohesive subpart. Finally, this final rule with comment period allows for further public comment on the Average Manufacturer Price and Federal upper limit (FUL) outlier section of the rule.

Total Amount Awarded: $600,000. Total Number of Awards: One (1). Description of Opportunity: The Office of Disease Prevention and Health Promotion (ODPHP)/Office of Public Health and Science (OPHS), announces a competitive cooperative agreement project titled Disease Prevention and Health Promotion Scholarship Program for up to $600,000, in the fiscal year (FY) 2007 for a 5 year period, subject to available funding. This project seeks to provide disease prevention and health promotion educational and training opportunities for medical and public health students; preventive medicine and primary care residents; and practicing physicians and public health professionals. Eligibility: To qualify for funding, an applicant must be a professional non-profit organization, association, or institute of higher learning that focuses or has as its mission to educate one or more of the following groups: Medical and/or public health students, preventive medicine and primary care residents; and practicing physicians from communities across the country. Eligible applicants are also encouraged to apply in partnerships. Faith-based groups that meet the definition of professional non-profit organization or institution of higher learning as described above are also eligible to apply.

The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.

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.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

This notice announces the 15th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The DHHS Agency for Healthcare Research and Quality (AHRQ) invites nominations from interested organizations and knowledgeable individuals for a Stakeholder Group to support the work of the Effective Health Care Program, funded under Section 1013 of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The goals of this program are to develop evidence on the effectiveness and comparative effectiveness of different treatments and health care interventions of importance to the Medicare, Medicaid, and State Child Health Insurance. To achieve these goals, AHRQ is supporting projects to review, synthesize, generate and translate published and unpublished scientific evidence, as well as identify important issues for which existing scientific evidence is insufficient to inform decisions about health care. This evidence will be made readily available to all heath care decision-makers. The Stakeholder Group is critical to the success of this project, providing input to the program in collaboration with the Effective Health Care Scientific Resource Center (currently based at the Oregon Evidence-based Practice Center). The role of the Stakeholder Group will be to: Provide input on critical research information gaps for practice and policy and on identifying and developing the key research questions to address these gaps. Provide input on implementation issues for Effective Heath Care program reports and findings. Define information needs and identify types of projects that will be most useful. Provide feedback from report users. Provide guidance on the program as a whole for quality improvement. Provide guidance on how the program can have more of an impact with users. Members will serve as volunteers for a two-year period from October 2007 through September 2009. Stakeholder Group members will attend 3-4 meetings per year as part of this process. Meetings will be held in Rockville, MD and Portland, Oregon. Meetings will be 1-2 days in length. The Scientific Resource Center (SRC) will make the travel arrangements. The first meeting will be held on October 26, 2007, in Rockville, MD. Members are expected to actively participate in meetings and to engage in related activities by phone and e-mail between meetings. Between-meeting work may include assisting with agenda planning and session preparation for Stakeholder meetings, consulting with SRC or AHRQ staff on constituency issues, and serving as a resource to the Effective Health Care Program. It is anticipated that the Stakeholder Group member time commitment between meetings will not exceed 10 hours. The Stakeholder Group will be composed of up to 15 members. The group will represent several broad constituencies of stakeholders and decision-makers at the policy, system, and clinical levels, which will include: Third party healthcare payers (including, but not limited to public State or Federal Medicare or Medicaid programs, and private insurance health plans and Health maintenance Organizations). Employers and health-related business groups. Pharmacy and therapeutic committees. Healthcare providers. Patient/consumer organizations. Consumers of Federal and State beneficiary programs. Healthcare industry professional organizations. Academic researchers (including, but not limited to those with expertise in evidence-based methods and effectiveness and translational research). Self-nominations are encouraged. Materials to be submitted are a cover letter and curriculum vitae or similar supportive documentation. The cover letter will provide information on how the nominee's experience, skills and roles fit with the composition and goals of the Stakeholder Group as described above. Specific information on nominee experience in the constituency groups described above is required. Nominees chosen for the Stakeholder Group will be required to declare and submit conflict of interest documentation. This will not necessarily preclude service. Nominees may indicate their willingness to be considered in subsequent calls for nominations if not selected for this Stakeholder Group in their supporting documentation. All nominations received by submission deadline will be reviewed by a committee composed of representatives from AHRQ and the SRC. Nominees who best represent the broad constituencies described as the goal for composition of the Stakeholder Group will be selected and notified by September 28, 2007. In addition, AHRQ is interested in fostering diversity and including representatives of, or individuals with expertise regarding, populations experiencing health care disparities and in this case individuals with expertise regarding chronic conditions and health care needs of the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) populations.

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 Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 75-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). In the Federal Register of June 11, 2007 (72 FR 32030), the agency proposed to remove the essential use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking.