Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents

This notice provides public announcement of CDC's intent to award two awards to eligible applicants of State or Territorial Public Health Newborn Bloodspot Screening Programs. These activities are proposed by the above-mentioned grantees in their FY 2011 applications submitted under funding opportunity CDC-RFA-EH11-001, ``Program to Support New Implementation of State or Territorial Public Health Laboratory Capacity for Newborn Bloodspot Screening of Severe Combined Immune Deficiency (SCID) (U01), '' Catalog of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $900,000 in funding will be awarded to the grantees for the implementation of newborn screening for SCID. Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH11-001:

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for Medical Devices.'' FDA is cosponsoring the conference workshop with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and the National Science Foundation (NSF). The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development and evaluation of medical devices. Dates and Times: The public workshop will be held on September 7, 8, and 9, 2011, from 9 a.m. to 5 p.m. An optional FDA Microstructure Modeling session will be held from 1 to 5 p.m. on September 6, 2011. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m. Persons interested in attending this public workshop must register by 5 p.m. on August 30, 2011. Location: The public workshop and optional session will be held at the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993- 0002. Contact Persons: Donna R. Lochner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3220, Silver Spring, MD 20993-0002, 301-796-6309, e-mail: donna.lochner@fda.hhs.gov; or Tina M. Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1272, Silver Spring, MD 20993-0002, 301-796-6310, e-mail: tina.morrison@fda.hhs.gov. Registration: To register for the public workshop and optional session, please visit the following Web site: https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to https://www.fda.gov and select the FDA Medical Devices News & Events Workshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. For those without Internet access, please call the contact person to register. Registration is mandatory as space is limited and onsite registration will not be available. FDA may limit the number of participants from each organization. There is no registration fee for the public workshop. Registrants requesting to present written materials or to make oral presentations at the public workshop, please call the contact persons by August 23, 2011. If you need special accommodations because of a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD 20993-0002, 301-796-5661 at least 7 days before the public workshop.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule published in the Federal Register of December 8, 2010, proposing to amend regulations on plant sterol/ stanol esters and risk of coronary heart disease (CHD). FDA is reopening the comment period because the Agency received a request for additional time to comment on the proposed rule.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers'' dated August 2011. The guidance announced in this notice amends the October 2006 guidance document of the same title by incorporating a revised response to question 12 (Q12). The revised response concerns the ability of vaccine manufacturers to use alternative coding technologies to the linear bar code requirement. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers (Question 12 Update)'' dated August 2010, and is superseding the guidance entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers'' dated October 2006.

In FY2011, HHS/ASPR/OPP plans to provide a Single Source Cooperative Agreement Award to the Pasteur Foundation to build and strengthen core capacities for influenza preparedness and response in support of International Health Regulations (2005) implementation in Sub-Saharan Africa and Southeast Asia. ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC), will collaborate with the Pasteur Institute and Pasteur Institute affiliates in Cameroon, Central African Republic, and Senegal in Africa, and Cambodia in Asia to develop and implement activities for preparedness and response for pandemic influenza with applicability to other emerging respiratory infections and public health threats in general. The project will focus on building upon existing routine health systems to further develop IHR (2005) core capacities including communication (IHR National Focal Point communication), workforce development, and surveillance and laboratory diagnostics. This work will be performed in the context of Article 44 of the IHR (2005), which directs State Parties to collaborate with each other to detect, assess, and respond to events, and to develop, strengthen, and maintain core public health capacities for surveillance and response.

The ``Lifeline Facebook App Challenge'' is a challenge aimed at multidisciplinary teams of technology developers, entrepreneurs, and members of the disaster preparedness, response and recovery communities to use Facebook as a platform for connecting individuals together through an application (app) that will provide actionable steps for Facebook users to increase their own personal preparedness and strengthen connections within their social networks for the sake of personal preparedness and community resilience. This challenge will provide useful tools for public health promotion and protection, a key goal for the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

The Department of Health and Human Services is hereby giving notice that the charter for the Presidential Advisory Council on HIV/ AIDS (PACHA; the Council) has been renewed.

The Department of Health and Human Services is hereby giving notice that the National Vaccine Advisory Committee (NVAC) has been rechartered.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three approved new animal drug applications (NADAs) for dosage form products containing moxidectin from Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc.

The Food and Drug Administration (FDA) is announcing that Lanxess Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of calcium formate in poultry and swine feed as a nutrient and digestive aid.