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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription drug products. Self-selection studies are conducted to ensure that consumers are able to make the correct decision to use, or not use, a nonprescription drug product based on their personal medical situation.

The Food and Drug Administration (FDA) is announcing the availability of an updated information technology (IT) plan entitled ``PDUFA IV Information Technology Plan'' (updated plan) to achieve the objectives defined in the Prescription Drug User Fee Act (PDUFA) Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications. The FDA is publishing the updated plan for comment to allow the public to provide feedback as the Agency moves towards a fully electronic standards-based submission and review environment.

The U.S. Department of Health & Human Services' Office of the National Coordinator for Health Information Technology (ONC) is leading a national campaign to educate and engage the public on the value and benefits of health information technology (health IT) in improving health and health care. As part of the campaign, we encourage entities that touch Americans' lives to pledge to empower individuals to be partners in their health through health IT. There are two types of pledges: One for those who manage or maintain individually identifiable health data (e.g., providers, hospitals, payers, retail pharmacies) and another for those who do not manage or maintain consumer health data, but have the ability to educate consumers about the importance of getting access to and using their health information (e.g., employers, consumer and disease-based organizations, healthcare associations, product developers). Taking the pledge is voluntary, and does not represent any endorsement by the U.S. Department of Health and Human Services or any other part of the federal government. To learn more about the details of the pledge, please visit: http:/ /www.healthit.gov/pledge. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.

In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group can be obtained by accessing the following Web site: https://www.healthcare.gov/center/ councils/nphpphc/.

The Food and Drug Administration (FDA) is amending the animal drug regulations to update the allowable incremental increase for residues of progesterone in edible tissues of cattle and sheep based on the 1994 revised daily consumption values. This action is being taken to improve the accuracy of the regulations.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-sixth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.

The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) are announcing the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. FDA and FSIS are particularly interested in research that will help both organizations understand current and emerging practices by industry in sodium reduction in foods; current consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices; motivation and barriers in reducing sodium in their food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction of excess sodium intake. Excess sodium intake is linked to increased risk of heart disease and stroke. FDA and FSIS recognize ongoing efforts by a number of members of the restaurant and packaged food industries to reduce sodium and appreciate the complexities of reducing sodium in foods. Continued input and support from industry and other stakeholders are important to support further progress on this significant public health issue.

Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

HHS gives notice of a decision to designate a class of employees from the General Electric Co. in Evendale, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 31, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component 2012- 2013.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 30th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.