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

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: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3-15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and non-profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/ policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 32,958. The annualized cost to respondents is estimated at $213,764.58. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.

We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

The Indian Health Service published a document in the Federal Register on June 8, 2011, concerning competitive cooperative agreement applications to establish Tribal Epidemiology Centers serving American Indian/Alaska Native Tribes and urban Indian communities. The document contained one incorrect date.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based Devices.'' This draft guidance document provides industry and Agency staff with recommendations for studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of methicillin-resistant S. aureus (MRSA), including those for the detection or detection and differentiation of MRSA versus S. aureus (SA) in either human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time.

The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. This meeting is open to the public and prior registration is required. The public may attend in-person or by teleconference.

This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the third 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.