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

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 Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.

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 Food and Drug Administration (FDA) is announcing the establishment of a public docket to receive comments related to surgeon's gloves and patient examination gloves (medical gloves) that contain or use donning or dusting powder. FDA is interested in the potential health effects from the use of powder on medical gloves and is soliciting comments regarding risks and benefits of powdered gloves. FDA is interested in any potential benefits of powdered gloves so that the Agency can consider how best to address the risks in light of any benefits. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for a draft guidance document entitled ``Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use Powder.'' The draft guidance document provides a recommended warning statement for powdered glove labeling that will inform health care providers and consumers of the risks associated with glove powder.

The National Center for Complementary and Alternative Medicine (NCCAM) invites the research community to participate in a Workshop on Clarifying Directions and Approaches to Mechanistic and Translational Research on Omega-3 Fatty Acids and their Metabolites. The purpose of this workshop is to bring together researchers from a variety of fields to discuss cutting edge mechanistic and translational research related to the underlying mechanisms of Omega-3 fatty acids and their metabolites. The goal is to identify opportunities to move Omega-3 fatty acid of research forward by highlighting barriers to progress with potential solutions and elucidation of gaps in the field which can be addressed. The Workshop will take place on February 14-15, 2011. Location: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. For registration information please contact Dawn Wayman at 301.594.9877 or waymandm@mail.nih.gov. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. NCCAM funds research grants that explore the science of CAM. For more information, see https://nccam.nih.gov/. Participating: Other institutes participating in this workshop include: the Office of Dietary Supplements (ODS), National Cancer Institute (NCI), National Heart, Blood and Lung Institute (NHLBI), National Institute of Mental Health (NIMH), National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Eye Institute (NEI).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), 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 November 15, 2010, pages 69680-69681, and allowed 60 days for public comment. One comment was received. The comment questioned the value and utility of the proposed data collection, stating that this type of research is not needed. 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: Pilot Study for the National Children's Study Type of Information Collection Request: Revision. Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18-49 years of age, their husbands or partners, and their children who live in selected areas within National Children's Study sites. Health care professionals, community leaders, and child care personnel are also potentially affected. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of the proposed methodological study is to continue the Vanguard phase of the National Children's Study (NCS) to evaluate the feasibility, acceptability, and cost of recruitment strategies and study design elements for a prospective, national longitudinal study of child health and development. In combination, the sub-studies encompassed by the Vanguard Phase will be used to inform the design of the Main Study of the National Children's Study. We propose to continue data collection among the 37 Vanguard Study locations up to and including the visit planned to take place when the sample children have reached 24 months of age. This would align study visits approved for the initial 7 Vanguard Study locations (which extend past the birth visit to include a 3-, 6-, 9-, 12-, 18- and 24- month visit) with the study visits approved for the 30 additional Vanguard Study locations (which were initially proposed and approved up to and including the birth visit). Extending the data collection of the 30 additional Vanguard Study locations to 24 months of age would support rigorous, empirical evaluation of participant retention as it may relate to recruitment strategy. A strong understanding of how to encourage retention of study participants, particularly during the infancy and early childhood years, will be essential to planning the Main Study. Additionally, continuing data collection post-birth among the alternate recruitment strategy study locations allows us to generate additional data to inform the development of study visit procedures, both for future Vanguard Study efforts and the Main Study. We also propose reintroduction of a limited set of study visit measures to all 37 of the Vanguard Study locations engaged in data collection. Recall that extensive measures, including biospecimens, were previously approved for use in the initial 7 Vanguard Study locations. When the additional 30 locations were added, we streamlined data collection to allow focus on improving recruitment rates. Now that we have the training for those new locations (and retraining for the initial locations) completed, it is an opportune time to reintroduce selected measures that have the benefit of field experience. That field experience has been used to improve their scientific robustness, burden, and cost. These improved measures now require field testing to best inform their suitability for the Main Study. Specifically, we would like to reincorporate a father interview; maternal blood and urine collection; infant cord blood collection; home tap water and dust collection; a pregnancy health care log; and an infant and child health care log. In addition to supporting further testing of refined items, including these measures in the Recruitment Substudy would result in a data collection scope more closely mirroring the anticipated scope of the Main Study, thereby allowing better gauge of data collection scope and resources and the relationship with retention and study logistics over time. We will evaluate the feasibility (technical performance), acceptability (respondent tolerance and impact on study infrastructure), and cost (operations, time, and effort) of each recruitment and retention strategy using pre-determined measures. We will compare these findings and use them as a basis to inform the strategies, or combinations of strategies, that might be used in the Main Study of the NCS. Further details pertaining to the NCS background and planning can be found at: https://www.nationalchildrensstudy.gov. Burden statement: The additional public burden for this study will vary depending on the method of recruitment. The table below provides the annualized average burden per person over the two-year data collection period for all three alternate recruitment strategies. The additional annualized cost to respondents over the two-year data collection period for the 30 locations engaged in the alternate recruitment strategies to extend data collection from birth to age 2 is estimated at $82,000 (based on $10 per hour) and the differential time estimates in Table A.2.e, below. To reintroduce the proposed measures into the 30 locations engaged in the alternate recruitment strategies, the annualized cost to respondents over the same period is estimated at an additional $79,000 (based on $10 per hour) and the differential time estimates in Table A.2.e, below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. BILLING CODE 4140-01-P [GRAPHIC] [TIFF OMITTED] TN04FE11.002

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for a new animal drug intended for a minor use filed by AB Science. The application for conditional approval provides for the veterinary prescription use of masitinib mesylate tablets in dogs.

The Food and Drug Administration (FDA) Southwest Regional Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), the Mid-Continental Association of Food and Drug Officials (MCAFDO), and the FDA Medical Device Industry Coalition, is announcing a public workshop entitled ``The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market''. This 2- day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. Date and Time: The public workshop will be held on June 20 and 21, 2011, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Dallas/ Plano at Legacy Town Center, Plano, Texas, 7120 Dallas Pkwy., Plano, Texas 75024, 972-473-6444, or toll-free 888-236-2427. Attendees are responsible for their own accommodations. To make reservations at the Marriott Dallas/Plano at Legacy Town Center, at the reduced conference rate, contact the Marriott Dallas/Plano at Legacy Town Center before May 20, 2011, citing meeting code ``AFDO Conference''. Contact: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX: 214-253-4970, e-mail: David.Arvelo@fda.hhs.gov. Registration: You are encouraged to register by May 24, 2011. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; therefore, please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration follows:

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Committee is the responsibility of the NVPO. Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

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 Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``PET Drug Applications Content and Format for NDAs and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations. This draft guidance revises the draft guidance entitled ``Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability,'' issued on March 10, 2000. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to assist applicants in preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging.

This notice provides the adjusted Federal Medical Assistance Percentage (FMAP) rate for the first quarter of Fiscal Year 2011 (FY11) as required under Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for temporary increases in the FMAP rates to provide fiscal relief to states and to protect and maintain state Medicaid and certain other assistance programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period that was originally defined in ARRA as the period beginning October 1, 2008 and ending December 31, 2010. Public Law 111-226 amended ARRA to extend the recession adjustment period to June 30, 2011 and to extend the hold harmless provision that prevents a state's FMAP rate from decreasing due to a lower unemployment rate from the calendar quarter ending before July 1, 2010 to the calendar quarter ending before January 1, 2011. Public Law 111-226 also provided for a phase-down of the general FMAP increase in the last two quarters of the extended recession adjustment period, and changed the look back period for calculating the unemployment adjustment for those quarters, which will be addressed in a future Notice.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2010 Service Contract inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2010. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/sites/default/files/ omb/procurement/memo/service-contract-inventories-guidance- 11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/servicecontractsfy10.html.