SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Patient-Reported 
Outcome Measures: Use in Medical Product Development to Support 
Labeling Claims.'' This guidance describes how FDA reviews and 
evaluates patient-reported outcome (PRO) instruments used to measure 
treatment benefit in medical product clinical trials. It also provides 
recommendations on how sponsors can use study results measured by PRO 
instruments to support claims in approved medical product labeling. 
This guidance finalizes the draft guidance published on February 3, 
2006.

DATES: Submit written or electronic comments on agency guidances at any 
time.

The Genetic Information Nondiscrimination Act of 2008 (P.L. 110-233, 122 Stat. 881)1, also referred to as GINA, is a new Federal law that prohibits discrimination in health coverage and employment based on genetic information. The President signed the act into law on May 21, 2008. The section of the law relating to health coverage (Title I) generally will take effect between May 22, 2009, and May 21, 2010.2 The sections relating to employment (Title II) will take effect on November 21, 2009. GINA requires regulations pertaining to both titles to be completed by May 2009.

How does the Federal law affect state laws?

GINA provides a baseline level of protection against genetic discrimination for all Americans. Many states already have laws that protect against genetic discrimination in health insurance and employment situations. However, the degree of protection they provide varies widely, and while most provisions are less protective than GINA, some are more protective. All entities that are subject to GINA must, at a minimum, comply with all applicable GINA requirements, and may also need to comply with more protective State laws.

Effective Date:This rule is effective April 6, 2009

This rule finalizes our proposal to delay enforcement of certain clarifications regarding standards for determining hold harmless arrangements in the final rule entitled, ‘‘Medicaid Program; Health Care- Related Taxes’’ from the expiration of a Congressional moratorium on enforcement from July 1, 2009 to June 30, 2010

Effective Date:This rule is effective July 1, 2009.

This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016

Effective Date:This rule is effective October 1, 2009.

This final rule temporarily delays the effective date of the November 25, 2008 final rule entitled, ‘‘Medicaid Program; Premiums and Cost Sharing’’ and the December 3, 2008 final rule entitled, ‘‘Medicaid Program; State Flexibility for Medicaid Benefit Packages’’ until July 1, 2010

Effective Date:This rule is effective December 31, 2009.

This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016