Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing that the charters have been renewed for the following federal advisory committees for which Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood Safety and Availability (ACBSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)[Extension] Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act), ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that a manufacturer who participates in Medicaid must sign a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge enrolled covered entities a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B Drug Pricing Program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution process for manufacturers and covered entities, as well as manufacturer guidelines for audit of covered entities (Federal Register Final Notice, December 12, 1996 (Vol. 61, No. 240, pp. 65406-65413)). Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:

The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Ajinomoto Co., Inc., to indicate that the petitioned additive, N-[N-[3-(3-hydroxy-4- methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20- 6), is for use as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. The previous filing notice indicated that the proposed additive was for use as a non-nutritive sweetener in tabletop applications and powdered beverage mixes.

The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source year program expansion supplement in the amount of $250,000 to the Regents of the Board of the University of Michigan, Ann Arbor, MI, to provide more intensive technical assistance and conduct a rigorous evaluation of research and demonstration sites.

The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement in the amount of $420,000 to the Research Foundation of CUNY on behalf of Hunter College School of Social Work, New York, NY, to provide targeted technical assistance to address continuing challenges in the field as child welfare programs work to implement the requirements of new legislation. The Research Foundation of CUNY on behalf of Hunter College is the recipient of a cooperative agreement to act as the administrator for the National Resource Center for Permanency and Family Connections (NRCPFC).

The Food and Drug Administration (FDA) is announcing the rate for the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes FY 2013 rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 4C0276) proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products.

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 Heart, Lung, and Blood Institute (NHLBI), 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: The Jackson Heart Study: Annual Follow- up with Third Party Respondents. Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925- 0491). Need and Use of Information Collection: This project involves annual follow-up by telephone of participants in the JHS study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in African American men and women. Recruitment of 5,500 JHS participants began in September 2000 and was completed in March 2004. 5,302 participants completed a baseline Exam 1 that included demographics, psychosocial inventories, medical history, anthropometry, resting and ambulatory blood pressure, phlebotomy and 24-hour urine collection, ECG, echocardiography, and pulmonary function. JHS Exam 2 began September 26 2005, followed by a more comprehensive Exam 3 that began in February 2009. The two new exams include some repeated measures from Exam 1 and several new components, including distribution of self-monitoring blood pressure devices. The continuation of the study allows continued assessment of subclinical coronary disease, left ventricular dysfunction, progression of carotid atherosclerosis and left ventricular hypertrophy, and responses to stress, racism, and discrimination as well as new components such as renal disease, body fat distribution and body composition, and metabolic consequences of obesity. The JHS Community Health Advisor Networks (CHANs) comprise another component of the study. The JHS data shows high prevalences of risk factors: 73% of recruited participants are hypertensive, 29% are diabetic, 56% are obese (BMI > 30kg/m2), and 30% have the metabolic syndrome. Exploration of the impact on and interaction of high risk factor levels with other measures of clinical and subclinical disease will help identify unique approaches through epidemiology and prevention research to reduce the disproportionate burden of CVD in African-Americans. . The JHS CHANs play an important role to address CVD prevention by providing training to community members to spread health promotion and prevention messages within the Jackson community. The JHS Community Health Advisors (CHAs) are trained and certified to organize and conduct various outreach activities in five Jackson-area communities. Data on the JHS CHAs will be collected. Frequency of Response: One-time. Affected Public: Individuals or households; Businesses or other for profit; not-for-profit institutions. Type of Respondents: Middle aged and elderly adults; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 478; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 2.47); and Estimated Total Annual Burden Hours Requested: 1253. The annualized cost to respondents is estimated at $24,206. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 Administration for Children and Families, Administration on Children, Youth and Families, Children's Bureau (CB) awarded the National Quality Improvement Center on Differential Response (QIC-DR) cooperative agreement to the American Humane Association on September 30, 2008. On April 13, 2012, the American Humane Association submitted a letter relinquishing its grant effective June 30, 2012. The University of Colorado, Kempe Center for the Prevention and Treatment of Child Abuse & Neglect (Kempe Center), Denver, CO, an eligible organization, submitted its letter along with its grant application requesting approval as the replacement grantee for the QIC-DR grant. CB has received and reviewed the application from the Kempe Center. For the remainder of the project period listed below, this organization has been awarded funds in the amount of $3,028,694 as the permanent replacement grantee.