Department of Health and Human Services April 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until May 18, 2007, the comment period for a notice of public meeting that published in the Federal Register of January 5, 2007 (72 FR 574). In the notice, FDA announced a February 7, 2007, meeting to solicit input on issues that the agency should consider if it decides to propose revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs. FDA is reopening the comment period in light of continued public interest in this topic.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This program is authorized by 42 U.S.C. 300u-2(a). The mission of the Office on Women's Health (OWH) is to promote the health of women and girls through gender-specific approaches. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These include supporting collaborative efforts to provide accurate prevention education to rural women living in the rural\1\ south\2\ rural South. The emphasis of these efforts is on educational and prevention counseling covering the full spectrum of primary and secondary prevention adapted to a female centered perspective. This initiative is intended to demonstrate a collaborative partnership approach between the grantee and local health or social service providers, e.g., community health centers, rural health centers, family planning clinics, the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), community based organizations, faith based organizations, public assistance programs and local health departments.

The Food and Drug Administration (FDA) is announcing that Durand-Wayland, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a carbon dioxide laser for etching information on food, excluding meat and poultry.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstration, evaluation, and research studies administered by ORDI. Sixteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``End Stage Renal Disease Program Management and Medical Information System,'' System No. 09-70-0520, last published at 67 FR 41244 (June 17, 2002); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

This notice announces the 13th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

This final rule establishes competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act. These competitive bidding programs, which will be phased in over several years, utilize bids submitted by DMEPOS suppliers to establish applicable payment amounts under Medicare Part B.