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

A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would generate an immediate global public health response. WHO must rely on fast and reliable laboratory diagnostic capacity worldwide to be able to identify a re-emergence of smallpox, particularly in countries where systemic orthopoxvirus infections such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion. Over the past 10 years, clinical virology laboratory diagnostics has been evolving and increasingly rely on molecular techniques. This is also true with laboratory diagnoses of poxvirus infections. Precise and consistent identification of orthopoxviruses, in particular variola viruses, is now achievable using such molecular techniques as real-time Polymerase Chain Reaction (unlike earlier techniques that may have relied on direct virus isolation and identification). WHO must be alerted when there is a potential or actual smallpox infection. Early detection and confirmation of smallpox cannot rely solely on the two WHO Collaborating Centres for smallpox and other poxvirus infections. In order to facilitate and support a prompt and effective response to mitigate the spread of the disease, these two Centres should be supported by a worldwide network of reliable laboratories able to perform PCR and real-time PCR diagnostics enabling initial detection and identification of smallpox events. Additionally, the U.S. Government supports the development of other medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies, which require access to the Variola virus to satisfy regulatory requirements for product approvals.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 3, 2012 (77 FR 46441). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The document published with incorrect FDA form numbers. This document corrects those errors.

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.

Under the provisions of Section 3507(a)(1)(D) 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 review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 24, 2012 (77 FR 11136) and allowed 60 days for public comment. There was one public comment that was not relevant to the scope, methodology, or burden of the study. The program staff submitted a response to the public comment. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health 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. Proposed Collection: Title: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) (OMB No. 0925-0654). Type of Information Collection Request: Extension. Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in the United States and in many other parts of the world. The contribution of environmental, occupational, and genetic factors to the cause of lymphoma has generated a series of new findings from epidemiological studies conducted in the United States that have attempted to explain this increase. This study focuses on collecting critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population, the incidence of which has risen in recent decades. Specifically, environmental exposures to industrial emissions, genetic susceptibility, viral exposures, early life exposures, ultraviolet (UV) radiation exposures, and other risk factors for lymphoma overall and specifically for populations in Asia will be examined. Patients from 19 participating hospitals will continue to be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Newly diagnosed patients with lymphoma or patients undergoing surgery or other treatment for non-cancer related medical issues who live in Taiwan and in Hong Kong, Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 5,302 hours (see Table below). There are $77,000 in Capital Costs, Operating Costs, and/ or Maintenance Costs to report.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 waiver applications.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the notice of a public webcast concerning compliance with the Federal Select Agent Program. The purpose of this notice is to notify all interested parties, including individuals and entities possessing, using, or transferring biological agents and toxins listed in 7 CFR 331.3, 9 CFR 121.3 and 121.4, or 42 CFR 73.3 and 73.4, of the webcast. The webcast is organized by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC), and the Department of Justice's Federal Bureau of Investigation (FBI). Issues to be discussed include changes to the select agent regulations; occupational health, information and physical security; personnel suitability; Bioterrorism Security Risk Assessment Form (FD-961 form); and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Wayne E. Spencer from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Spencer was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the FD&C Act. Dr. Spencer was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, but failed to respond. Dr. Spencer's failure to respond constitutes a waiver of his right to a hearing concerning this action.

This Notice advises the public that the Indian Health Service (IHS) established the geographic boundaries of the Service Delivery Area (SDA) for the newly recognized Mashpee Wampanoag Indian Tribe. The SDA was established on December 22, 2008 and services were provided to eligible beneficiaries beginning on January 19, 2009. The Mashpee SDA is comprised of Barnstable, Bristol, Norfolk, Plymouth and Suffolk counties in the State of Massachusetts. The counties listed are designated administratively as the SDA, to function as a Contract Health Service Delivery Area (CHSDA), for the purposes of operating a Contract Health Service (CHS) program pursuant to the Indian Self- Determination and Education Assistant Act (ISDEAA), Public Law 93-638.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.