Department of Health and Human Services September 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate; salmeterol xinafoate.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ``Investigational New Drug Applications (INDs)Determining Whether Human Research Studies Can Be Conducted Without an IND.'' The guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and IRBs in determining whether human research studies must be conducted under an IND. The guidance describes the basic criteria for determining when an IND is required, describes specific situations in which an IND is not required, and addresses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to Massachusetts Office for Refugees and Immigrants, Boston, MA, in the amount of $325,000 under the Wilson- Fish Program. The supplemental award will allow the grantee to provide refugee cash assistance (RCA) to arriving refugees and others who are also eligible for refugee benefits through the remainder of the current budget period. The expansion supplement award will enable the grantee to provide assistance to a higher number of clients than originally planned. RCA is provided to clients for up to 8 months upon arrival to the U.S. who are categorically ineligible to receive cash assistance through the State TANF program but otherwise meet the program's financial eligibility requirements.

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, National Institute of Allergy and Infectious Diseases, 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. 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Dione Washington, Strategic Planning and Evaluation Branch, OSPIDA, NIAID, NIH, 6610 Rockledge Dr, Rm 2501 Bethesda, MD 20892-6620, or Email your request, including your address to washingtondi@niaid.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Data Collection to Understand How NIH Programs Apply Methodologies to Improve Their Research Programs (MIRP), 0925New, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: In this submission, NIAID is requesting an OMB generic clearance for formative research activities relating to the collection of data to assist the Institute in understanding the usefulness of a range of methodologies that are employed to increase organizational effectiveness. The Office of Management and Budget (OMB) and Office of Science and Technology Policy (OSTP) have instructed agencies to apply rigorous strategy management principles to ensure resources are directed at high-priority programs and avoid duplication of effort. A key aspect to ensuring resources dedicated to these programs are applied efficiently and effectively is to understand how NIH research programs apply methodologies to improve their organizational effectiveness. The degree of an organization's effectiveness is commonly recognized to be influenced by many factors. These can include the clarity of its purpose and strategy, how it allocates and structures its work, the processes used to carry out operations, the way technologies are used to support work, the people involved and their skills and abilities, the way relationships are managed with partners and stakeholders, and how leadership functions, particularly in terms of its ability to ensure that all the other components are aligned in supporting work towards the mission. Many methodologies are commonly employed in all sectors, including government, with the goal of increasing organizational effectiveness. Some examples of those used widely are strategic planning and strategy management, total quality management, change management, organizational assessment and intervention, organizational design, process improvement, leadership development, performance management, and workforce training and professional development, among others. There are many models and approaches to each of these methodologies. Each one can be implemented in a wide range of ways. Reflection on and learning from methodologies that have been used and the ways in which they have been employed is critical to continually ensuring that government functions effectively. The primary use for information gathered through voluntary survey pilot testing, surveys, focus groups, interviews, and collaborative data interpretation meetings to understand the use of strategy management in research programs supported by the NIH. The information will improve approaches to implementing strategic management, which will lead to more efficient use of resources. Results gathered in these data will be used to enhance implementation of methodologies to improve organizational effectiveness. The main goal of this information is to improve program outcomes and increase the efficiency of resource utilization. The knowledge gained from these collections will be used to strengthen the planning, implementation, and monitoring of NIH research programs, as well as to strengthen strategy management in NIH research programs. The questions asked, and the data to be collected are rooted in established business-based paradigms but specifically adapted for use (and relevance) in a biomedical research environment, in order to discern: (1) Factors that enhance (or inhibit) organizational effectiveness in research programs; (2) utility and acceptance of these kinds of efforts among biomedical researchers and research stakeholders. The results from this formative research project will inform quality improvement activities in several areas, including goal setting, capability and resource evaluation, operational efficiency, and performance monitoring. Utilized data collection methodologies will be administered in a manner that minimizes public information collection burden. These include, but are not limited to, surveys, focus groups, and/or cognitive interviews. Separate and distinct generic clearances are requested to facilitate the efficiency of submission and review of these projects as required by the OMB Office of Information and Regulatory Affairs. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4775.

This document corrects technical errors that appeared in the proposed rule published in the Federal Register on July 19, 2013, entitled ``Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Hospital Value-Based Purchasing Program; Organ Procurement Organizations; Quality Improvement Organizations; Electronic Health Records (EHR) Incentive Program; Provider Reimbursement Determinations and Appeals.'' This document extends the comment period for 10 days for the technical corrections set forth in this correcting document.

The Food and Drug Administration (FDA or we) is confirming the effective date of July 15, 2013, for the final rule that appeared in the Federal Register of June 12, 2013 (78 FR 35115). The final rule amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Prevention of Salmonella Enteritidis in Shell Eggs During ProductionRecordkeeping and Registration,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) notifies federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified laboratories and IITF is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.