Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to- Consumer (DTC) Television and Print Advertisements for Prescription Drugs. This study is designed to communicate quantitative information about product benefits in DTC print and television ads.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

This notice finalizes an amendment to the eligibility guidelines proposed on March 4, 2009 in the Federal Register (74 FR 9407). The purpose of this notice was to solicit comments on the amendment to the Program Eligibility Guidelines proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Program follow-up period.

This proposed rule amends the Federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by FDA for opioid dependence and used in federally certified and registered opioid treatment programs. Opioid treatment programs that use these products in the treatment of opioid dependence will adhere to all other Federal treatment standards established for methadone.

This notice invites comments, within ten (10) days of the June 16, 2009, HIT Policy Committee (the ``Committee'') meeting, on the Committee's discussions of and draft recommendations for the term ``meaningful use'' available at https://healthit.hhs.gov. Comments will be received by the Committee for consideration and further recommendations to the National Coordinator of Health Information Technology on the elements and measures of Meaningful Use of a certified EHR.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Lake Ontario Ordnance Works, Niagara Falls, New York, 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:

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.

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 Office of the Director, 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.

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to Emergency review and approve the information collection by July 1, 2009. Given the long term nature of this project and the Recovery Act timelines, the NCI has requested approval to conduct emergency processing of information collections pursuant to 5 CFR 1320.13. NIH cannot reasonably comply with the normal clearance procedures for information collection, because the use of regular procedures would delay the collection and hinder the agency in accomplishing its mission and meeting new statutory requirements, to the detriment of the public good. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.