E7-16074. Agency Information Collection Request; 60-Day Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Agency Information Collection Request. 60-Day Public Comment Request.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to [e-mail], or call the Reports Clearance Office on [phone]. Written comments and recommendations for the proposed information collections must be received within 60-days, and directed to the OS Paperwork.

Proposed Project

Meeting Request Routing System for MedicalCountermeasures.gov—New—Office of the Assistant Secretary for Preparedness and Response (ASPR)—Office of the Biomedical Advanced Research and Development Authority (BARDA).

Both naturally occurring and intentional public health threats have the potential to cause catastrophic harm in a variety of ways, including economic repercussions and adverse effects on health, in some cases leading to loss of life. To meet these challenges, federal government encourages open communication with its stakeholders in the research and development communities and in industry. One method of improving this communication will be through the MedicalCountermeasures.gov Web site. The two key functions of the MedicalCountermeasures.gov Web site will be (1) to centrally manage stakeholder requests for meetings with government to present product information related to medical countermeasures against public health disasters, both manmade and naturally occurring; and (2) to provide our stakeholders in industry and academia with information on government sponsored opportunities and events related to medical countermeasures.

In order to route product developers to the most appropriate personnel within the Department of Health and Human Services (HHS), HHS will collect some basic information about the company's product through MedicalCountermeasures.gov. Using this information and a routing system that has been developed with input from the participating agencies within HHS, including the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), MedicalCountermeasures.gov will route the meeting request to the appropriate person within HHS. HHS is collaborating with other agencies in the planning of this project, and hopes to expand this system to other agencies in the future. ASPR is requesting a three year clearance.

HHS expects that the respondents will be made up of developers of medical countermeasures to naturally occurring and intentional public health threats. Participation in this system will be completely voluntary, and the information that is submitted to the system is for information only. We anticipate that the respondents will make a request on average once a year.

The estimate of 225 respondents is based on the number of stakeholders from the target group who signed up for the Public Health Emergency Medical Countermeasures Stakeholders Workshop.

Estimated Annualized Burden Table

Type of respondent	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Developers of medical countermeasures to naturally occurring and intentional public health threats.	225	1	8/60	30
Total		225		30

Dated: July 30, 2007.

Seleda Perryman,

Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer.