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

The Food and Drug Administration (FDA) is withdrawing approval of 13 new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.

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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 25th, 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.

The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to a Stakeholder Roundtable. Attendees will meet the NCCAM Director and discuss the Center's new strategic plan, activities, and priorities. The Roundtable will take place: 8:30 a.m.- 11 a.m., Tuesday, April 26, 2011, Building 31, 6C, Room 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. To allow for meaningful interaction, space is limited. To attend, please RSVP by Friday, April 1, 2011, by contacting Carina May at 301- 915-9763 or cmay@thehillgroup.com. Representatives from professional medical societies as well as consumer organizations are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999. The mission of NCCAM is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care To date, NCCAM's efforts to meet its mission have been guided by NCCAM's strategic plans located on the NCCAM Web site at https:// nccam.nih.gov/about/plans/. Request for Participation: Representatives of stakeholder organizations are invited to provide input into the NCCAM's priorities and activities at a Stakeholder Roundtable. This event will give NCCAM stakeholders an opportunity to voice their opinions regarding future directions for research, training, outreach, and integration in complementary and alternative medicine (CAM). The Dialogue will be held: 8:30 a.m.-11 a.m., Tuesday, April 26, 2011, Building 31, 6C, Room 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. NCCAM's director will provide an overview of NCCAM's history and current activities, followed by a discussion with attendees. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. To allow for meaningful interaction, space is limited. To attend, please RSVP by Friday, April 1, 2011, by contacting Carina May at 301-915-9763 or cmay@thehillgroup.com.

This notice announces the fourth meeting of an advisory committee to the Center for Consumer Information and Insurance Oversight (CCIIO) in accordance with the Federal Advisory Committee Act. The meeting is open to the public and will be conducted by telephone. The purpose of the meeting is to assist and advise the Secretary of the Department of Health and Human Services' through CCIIO strategy to foster the creation of qualified nonprofit consumer- operated health insurance issuers.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Section 3001(c)(3) of the Public Health Service Act, as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires the National Coordinator for Health Information Technology (ONC) to update the Federal Health IT Strategic Plan (developed June 3, 2008) in consultation with other appropriate Federal agencies and in collaboration with private and public entities. Work on the five-year Plan began more than a year ago and has included collaboration across federal agencies, as well with the private sector via the HIT Policy Committee. This notice serves to announce that the public comment period for the Federal Health IT Strategic Plan is open through Friday, April 22 at 11:59 p.m. (Eastern). ONC welcomes and encourages all comments from the public regarding the Plan. In order for your comments to be read and considered, you must submit your comment via the Federal Health IT Buzz Blog: https:// www.healthit.gov/buzz-blog/.

The National Institutes of Health (NIH) is extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) the adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by 30 days and thus will end on April 24, 2011.

The Administration on Aging (AoA) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the Certification on Maintenance of Effort under Title III and Certification of Long-Term Care Ombudsman Program Expenditures for OAA Title III and Title VII Grantees.

On March 8, 2011, the Director of the National Institute of Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register (76 FR 12740) requesting information from the public on three questions regarding conditions relating to cancer for consideration under the World Trade Center Health Program. Written comment was to be received by March 31, 2011. NIOSH has received comment about extending the request for information to include persons living and working in the affected area. In consideration of that comment, the Director of NIOSH is modifying one of the questions posed in the Federal Register and extending the public comment period to April 29, 2011.

The Health Resources and Services Administration (HRSA) will transfer the remaining American Recovery and Reinvestment Act (ARRA) Capital Improvement Project (CIP) from Saint Vincent's Catholic Medical Centers (SVCMC) of New York, current grantee of record, to Sunset Park Health Council (SPHC), Inc. in order to continue primary health care services to low-income, underserved homeless patients in New York City.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.