Department of Health and Human Services July 2005 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Retiree Drug Subsidy Program (RDSP), System No. 09-70-0550.'' Under section 1860D-22 of the Social Security Act (the Act), employers and unions who continue to offer prescription drug coverage to their qualifying covered retirees are eligible to receive a tax-free subsidy for allowable drug costs. This amended provision of the Act is mandated by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). A qualifying covered retiree is a Part D eligible individual who is a participant or the spouse or dependent of a participant; covered under employment-based retiree health coverage that qualifies as a qualified retiree prescription drug plan; and not enrolled in a Part D plan. Employment- Based Retiree Health Coverage is defined as coverage of health care costs under a group health plan based on an individual's status as a retired participant in the plan, or as the spouse or dependent of a retired participant. The term includes coverage provided by voluntary insurance coverage as a result of a statutory or contractual obligation. The Medicare prescription drug benefit and retiree drug subsidy represent additional funding sources that can help employers and unions continue to provide high quality drug coverage for their retirees. The purpose of this system is to collect and maintain information on individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor or consultant; (2) support constituent requests made to a congressional representative; (3) support litigation involving the agency; and (4) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified 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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 9.'' The draft guidance document is intended to assist facilities and their personnel in meeting the Mammography Quality Standards Act (MQSA) final regulations.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption From Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Office of Community Services (OCS) within the Administration for Children and Families (ACF) announces that competing applications will be accepted for a new grant pursuant to the Secretary's authority under section 678(A) of the Community Services Block Grant (CSBG) Act, as amended, by the Community Opportunities, Accountability, and Training and Educational Services (COATES) Human Services Reauthorization Act of 1998 (Pub. L. 105-285). These activities must fund training and technical assistance resources for the Community Services Network to ensure that the needs of eligible entities and programs relating to improving program quality (including quality of financial management practices) are addressed to the maximum extent feasible; and incorporate mechanisms to ensure responsiveness to local needs. The proposed grants will fund training and technical assistance resources for the Community Services Network focusing on improving the quality of programs carried out under the CSBG act and the delivery of healthy marriage strategies among low income people served by local community action agencies. Specifically, OCS will offer one-year grants to fund a one year project period for the creation and dissemination of ``best practice'' technical assistance materials from local community organizations, including those that are faith-based, that have demonstrated success in promoting or sustaining healthy marriages among clients as part of an overall strategy to help low-income people achieve family and child development, and/or self-sufficiency goals. Special emphasis is being placed on the development and dissemination of ``best practice'' materials that focus on a wide range of low-income populations, including racial and ethnic minorities.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the National Bureau of Standards, Van Ness Street, in Washington, DC, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: National Bureau of Standards, Van Ness Street. Location: Washington, DC. Job Titles and/or Job Duties: All physicists that worked in the Radioactivity LabEast BuildingBuilding 2. Period of Employment: From 1943 through 1952.

This proposed rule would set forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. We are also proposing to implement the revised area labor market Metropolitan Statistical Area designations for calendar year 2006.

This notice is to inform interested parties of changes made to the Funding Opportunity for Projects to Establish Public Assistance Reporting Information System (PARIS) State Partnership Grants published on Monday, April 25, 2005, with a due date for applications of June 24, 2005, which is now extended until August 8, 2005. 1. The following changes are made to Section I, ``Funding Opportunity Description'': a. There will be separate grants awarded to each Member and Partner State, such that a Member State will no longer have fiduciary responsibility for its Partner State [page 21222]; b. The following paragraph is struck: ``After evaluation of all grant applications, and if chosen for an award, the Member state will be awarded a grant under which it will act as a fiduciary agent to the Partner state. The Member state will be responsible for all funding that is provided to its Partner state and will reimburse funding provided hereunder, as costs are incurred, for specific items delineated in its approved grant application budget and in accordance with HHS fiscal and grants management requirements.'' [page 21222] and replaced with: ``Separate applications for a partnership agreement must be submitted by both the Member State and the Partner State with separate budget requests. An application from a Partner State must identify its Member State and an application from a Member State must identify its Partner State. As costs are incurred for specific items delineated in the approved grant application budgets, States must adhere to HHS fiscal and grants management requirements.''; c. The phrase ``Member State'' is struck and replaced with ``State'' in the paragraph that reads: ``This list is meant to be illustrative, not exhaustive of the type of issues the Member state should address when preparing the application.'' [page 21222]; 2. The following changes are made to Section I, ``Funding Opportunity Description,'' under the ``parameters'' list [page 21222]: a. In the first sentence in paragraph (3), the phrase ``the Member State'' is replaced with ``each applicant'' so that the sentence reads, ``Each applicant must provide a proposed budget that includes the resources and associated costs it believes are necessary to participate in the match process.'' The second sentence is revised to read: ``The proposed budgets will be evaluated for adequacy, reasonableness, and to ensure that implementation of the partnership will be both operationally effective and successful''; b. The language in paragraph (5) is struck and replaced with: ``For Member States to be eligible for this funding opportunity they must have participated in at least two of the last six PARIS matches from (February 2004 through May 2005)''; c. The language in paragraph (6) is struck and replaced with: ``Applicants are cautioned that the ceiling for each grant award is $200,000 for a Partner State and $100,000 for a Member State. Applications exceeding the $200,000/$100,000 threshold will be considered non-responsive and will not be eligible for funding under this announcement''; d. The first sentence in paragraph (7) is struck and replaced with: ``Two applications must be submitted for each identified partnership One from a Member State and one from a Partner State.''; e. The language in paragraph (8) is struck and replaced with: ``The Partner State must enroll in the PARIS Project and provide a copy of the PARIS agreement to ACF prior to the grant award issuance in order to document the Partner State's consent to the project. The following link shows the PARIS Agreement: https://www.acf.hhs.gov/nhsitrc/paris/ agreepar.html ''; f. The language in paragraph (10) is struck and replaced with: ``Besides the Interstate and Veterans matches, States are encouraged to participate in any additional matches available, such as the Federal match.''; 3. The following changes are made to Section II, ``Award Information'': The ``Ceiling on the Amount of Individual Awards Per Project Period'' and the ``Average Projected Award Amount Per Project Period'' are revised as follows: ``$200,000 for a Partner State and $100,000 for a Member State'' [page 21223]; 4. The following changes are made to Section III.1, ``Eligibility Information, Additional Information on Eligibility'' [page 21223]: a. The first sentence is struck and replaced with, ``In the context of this grant announcement, eligible applicants include both Member States of PARIS and proposed Partner States as defined in Section I, ``Funding Opportunity Description.'' To be considered an eligible Member State, the State must have participated in at least two of the last six quarterly matches from February 2004 through May 2005.''; b. The sentence reading: ``The following States meet this eligibility factor'' now includes Oregon in the list of eligible Member States; c. The sentence that reads ``* * * and only these Member States may submit applications under this grant'' is struck and replaced with ``only these eligible Member States may qualify to submit applications under this grant announcement as Member States defined in this grant announcement.''; d. The sentence reading, ``The application must include the Partnership agreement as well as the appropriate signed PARIS agreement for the Partner State,'' is struck and replaced with: ``The application need only identify the other State in the Partnership in lieu of attaching the actual agreement; however, a signed PARIS agreement and Partnership agreement must both be provided to ACF prior to the grant award issuance.'' 5. The following changes are made to Section III (3), ``Eligibility Information, Other, Disqualification Factors'' [page 21223]: a. The sentence stating, ``Applications that are not submitted by a Member state,'' is struck and replaced with: ``Applications that are not submitted by a State.'' ; b. The following sentence is struck: ``Applications that fail to include a written Partnership agreement between the Member state and Partner state.''; c. The following sentence is struck: ``Applications that fail to provide a signed PARIS agreement by the Partner state.''; d. In the sentence that reads, ``Applications that fail to specify at least two of the last six quarterly PARIS matches from November 2003 through February 2005 in which the Member state has participated,'' the dates are struck and replaced with ``February 2004'' and ``May 2005'' respectively. 6. The following changes are made to IV.2, ``Application and Submission Information, Content and Form of Application Submission'': a. The sentence, ``Applications must contain a partnership agreement from the Partner State indicating its agreement to team with the Member State for purposes of this grant'' is struck and replaced with: ``Applications should identify what other State, be they a Member State or a Partner State, they are teaming with. The teaming or partnership agreement must be submitted to ACF prior to grant award issuance.'' [page 21223]; b. The sentence, ``Note that the application requires proof of an agreement between the PARIS Member State and its Partner State as well as a signed PARIS agreement (available on the PARIS website)'' is struck and replaced with: ``The proof of agreement between the PARIS Member State and its Partner State, as well as a signed PARIS agreement (available on the PARIS website), must both be submitted to ACF prior to grant award issuance.'' [page 21224]; 7. The following changes are made to Section IV. 3, ``Submission Dates and Times, Due Date for Applications'': The due date for applications is extended from June 24, 2005 to August 8, 2005. [page 21224]; 8. The following changes are made to Section IV.3, the ``Checklist'': Under the ``When to Submit'' column, the language for the PARIS Agreement and Partnership Agreement is replaced with, ``By date of award.'' [page 21225]; 9. The following changes are made to Section V, ``Application Review Information, Evaluation Criteria'' [page 21228]: a. The paragraph under the criterion ``Approach'' is struck and replaced with: ``Applications will be evaluated in terms of the extent to which they include a plan that (1) reflects the understanding of the characteristics, needs and services that are available from the PARIS Project and the potential for a Partnership agreement achieving the provision of services that directly address the fulfillment of the PARIS Project; (2) is appropriate and feasible; (3) can be reliably evaluated; (4) if successfully implemented, can be sustained after Federal funding has ceased.''; b. The point value for the criterion ``Budget and Budget Justification'' is revised from 10 points to 15 points; c. The entire criterion ``Third-Party Agreements'' worth 5 points is struck. 10. The second full paragraph in Section V(2), ``Review and Selection Process'' is revised to read: ``If an insufficient number of acceptable applications, as determined by ACF, are received under this program announcement ACF has the option of negotiating and awarding grant amounts higher than the $200,000 award ceiling for Partner States and $100,000 award ceiling for Member States, set forth in this announcement among those applicants who have submitted acceptable applications.''