Department of Health and Human Services October 18, 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 9, 2011, pages 48872-48873, and allowed 60 days for public comment. Two public comments were received. One comment questioned why government resources are being devoted to studying the health of Hispanic groups. The comment was acknowledged by NHLBI. The second comment, from an advocacy group, inquired about exploring the availability of paid sick leave and its relationship to Hispanic health. NHLBI acknowledged and followed-up on this comment. 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: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: Revision of currently approved collection (OMB 0925-0584). Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the U.S., are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six-and-a-half-year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 17,284; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.3072; and Estimated Total Annual Burden Hours Requested: 5,309. The annualized cost to respondents is estimated at $104,718, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, NIDA has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is extending to November 18, 2011, the comment period for the notice that appeared in the Federal Register of July 25, 2011 (76 FR 44338-44339). In the Notice, NIOSH announced its intent to hold a public meeting to discuss and obtain comments on the draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3- pentanedione'' with a comment period ending on October 14, 2011. A copy of the draft document was posted on the Internet at: https:// www.cdc.gov/niosh/docket/review/docket245/ for Docket number NIOSH-245. The agency is extending the comment period in response to requests for extensions to permit the public more time to gather and submit information.

The Food and Drug Administration (FDA) is extending the comment period to November 30, 2011, for the notice entitled, ``Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments'' that appeared in the Federal Register of August 1, 2011 (76 FR 45818). In that document, FDA announced the establishment of a docket to obtain information that would be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular, the Agency requested public comments on whether a reduction of fees or other consideration for small business was appropriate, and if so, what factors the Agency should consider for each. In addition, the Agency requested public comment on how small business should be defined or recognized. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.