Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is seeking public comment on the development of guidance concerning Health Risk Assessment (HRAs). Section 4103 of the Affordable Care Act (ACA) (Pub. L. 111-148) requires that a health risk assessment be included in the annual wellness visit benefit authorized for Medicare beneficiaries under the ACA. CDC is collaborating with the Centers for Medicare and Medicaid Services (CMS), also located within HHS, in the development of guidance for this type of assessment. This guidance is also intended to be useful for HRAs conducted in other patient populations such as privately insured populations, including those persons covered by employer healthcare plans. Comments received from this request for information will be used to inform the HRA guidance development process.

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 Institute of Child Health and Human Development (NICHD), 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.

Notice is hereby given of the cancellation of the Advisory Committee on Training in Primary Care Medicine and Dentistry, November 15, 2010, 8:30 a.m. to 4:30 p.m., and November 16, 2010, 8 a.m. to 2 p.m., at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20910, which was published in the Federal Register on October 19, 2010, FR Doc. 2010-26205 (75 FR 64318).

This final notice announces our decision to approve Det Norske Veritas Healthcare (DNVHC) for recognition as a national accreditation program for critical access hospitals seeking to participate in the Medicare or Medicaid programs.

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 Cancer Institute (NCI), 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: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2010. Type of Information Collection Request: Revision. Need and Use of Information Collection: The NCI has sponsored five Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a sixth to be administered in 2011. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the State. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2011 is planned for continual administration to 48,150 adults and 3,316 adolescent Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, obesity, and human papillomavirus. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 2,177 (see Table 1). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the Agency's regulations. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the Agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

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: ``Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is proposing to amend its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This proposed rule, once finalized, would specify the color graphics that must accompany each of the nine new textual warning statements.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondenceusually in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic, or from FDAintended to alert physicians and other health care providers to important new information about a marketed drug or biological product. This draft guidance provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products.

The U.S. Department of Health and Human Services, in its role as the Chair of the Interagency Working Group on Youth Programs, is announcing a meeting to solicit input from the public that will inform the development of a strategic plan for federal youth policy.

The Food and Drug Administration (FDA) is reopening until October 31, 2011, the comment period for the notice of public meeting that published in the Federal Register of March 16, 2010 (75 FR 12555). In the notice, FDA announced a public meeting to solicit input on the reauthorization of the Prescription Drug User Fee Act (PDUFA) program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires public review of the recommendations for the human drug review program after negotiations with the regulated industry conclude. FDA expects that this additional public process will be complete by October 2011. FDA is reopening the comment period for the expected duration of the public part of the reauthorization process to ensure that all interested stakeholders have the opportunity to share their views on the matter.