Department of Health and Human Services September 17, 2012 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget. The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0302 which expires on November 31, 2012. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. OS especially requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Deadline: Comments on the ICR must be received within 60 days of the issuance of this notice.

The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The document announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' The document was published with an incorrect docket number. This document corrects that error.

HRSA will be awarding to Vanderbilt University Medical Center, Nashville, Tennessee, a one-time non-competitive replacement grant for Part C funds to support comprehensive primary care services for persons living with HIV/AIDS, including primary adult HIV medical care, adult psychiatric and mental health therapy, nurse medical case management focused on treatment adherence, and referrals to specialty medical care. These funds will help to avoid a disruption of HIV clinical care to clients in Nashville, Tennessee, and the surrounding counties.