Notice of Availability of Draft Guidances To Assist in Preparation for an Influenza Pandemic, 31690-31691 [E8-12357]

Download as PDF 31690 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices to the OS Paperwork Clearance Officer at the above email address within 60 days. Proposed Project: Trends in U.S. Public Awareness of Racial and Ethnic Health Disparities (1999–2008)—NewOffice of Minority Health (OMH). Abstract: The proposed survey seeks to collect data for one of OMH’s annual performance measures, approved by OMB in February 2007, following Office of Management and Budget (OMB)’s examination of OMH using the Program Assessment Rating Tool (PART). This measure is to ‘‘increase awareness of racial/ethnic health status and health care disparities in the general population.’’ Findings from this data collection will enable OMH to track progress on this measure over time as mandated by OMB PART requirements. The lack of general awareness and understanding about the nature and extent of racial and ethnic health disparities in the U.S. and the impact that such disparities are having on the overall health of the Nation have been cited as a major barrier to the provision of programmatic, budgetary, and policy attention to these issues. Therefore, one of the long-term, annual measures agreed upon was to ‘‘increase awareness of racial/ethnic health status and health care disparities in the general population.’’ Additionally, OMH can use the findings about progress made in raising awareness to identify collaborative partners in the federal government, at the state and local levels, among businesses and non-profits, and among the faith community, in order to reach a wider audience. Further, these results can be used by program decision-makers and policy-makers, within and outside of HHS, who are interested in capturing progress made in the last eight years after exposing the U.S. population to information which confirms the existence, and societal effects, of racial and ethnic health disparities. ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents Number of responses per respondent Average burden per response (in hours) General Population .......................................................................................................... Physician .......................................................................................................................... 4,100 360 1 1 14/60 14/60 957 84 Total .......................................................................................................................... .................... .................... .................... 1,041 Type of respondent Terry Nicolosi, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E8–12290 Filed 6–2–08; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of Availability of Draft Guidances To Assist in Preparation for an Influenza Pandemic Office of the Secretary, Health and Human Services. ACTION: Notice of Availability. ebenthall on PRODPC60 with NOTICES AGENCY: SUMMARY: The Department of Health and Human Services (HHS) is seeking public comment on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The draft Guidances are now available on the HHS Web site https:// aspe.hhs.gov/panflu/antiviral-nmasks.htm Submit comments on or before July 3, 2008. ADDRESSES: Instructions for Submitting Comments: Electronic responses are DATES: VerDate Aug<31>2005 16:07 Jun 02, 2008 Jkt 214001 preferred. Comments on the Facemask and Respirator guidance may be addressed to Panflucomments1@hhs.gov. Comments on the Antiviral Use guidance may be addressed to Panflucomments2@hhs.gov. Comments on the Employer Antiviral Stockpiling guidance may be addressed to Panflucomments3@hhs.gov. Written responses should be addressed to U.S. Department of Health and Human Services, Room 434E, 200 Independence Avenue, SW., Washington, DC 20201, Attention: Pandemic Influenza Masks Comments, Attention: Pandemic Influenza Antiviral Comments, or Attention: Pandemic Influenza Employer Antiviral Comments, respectively. A copy of this Notice and the full text of the draft Guidances are available on the HHS Web site at https:// aspe.hhs.gov/panflu/antiviral-nmasks.htm and the PandemicFlu.Gov Web site at https:// www.pandemicflu.gov. Please follow instructions for submitting responses. The submission of comments in response to this notice should not exceed 25 pages for each guidance, not including appendices and supplemental documents. Any information you submit will be made public. Consequently, please do not send any proprietary, commercial, financial, business confidential, trade secret, or personal information that you do not wish to be made public. PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 Total burden hours Public Access: Responses to this notice will be available to the public in the HHS Public Reading Room, 200 Independence Avenue, SW., Washington, DC 20201. Please call (202) 690–7453 between 9 a.m. and 5 p.m. to arrange access. FOR FURTHER INFORMATION CONTACT: Ms. Julie Schafer, Office of the Assistant Secretary for Preparedness and Response, (202) 205–2882. SUPPLEMENTARY INFORMATION: Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be easily passed between humans. Because humans have little immunity to the new virus, many people may become ill and a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the United States (US) each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1000 of those infected. It is projected that based on this historical experience and given the current U.S. population, a pandemic today, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the U.S. alone. The U.S. Government (USG) has developed a comprehensive strategy to prepare for and respond to an influenza pandemic, including developing and E:\FR\FM\03JNN1.SGM 03JNN1 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices acquiring vaccine and antivirals to prevent and treat illness, planning for use of measures to reduce the spread of the disease by asking ill persons to stay home, voluntary quarantine of household members who live with an ill person, closure of child care facilities and dismissal of students from schools, decreasing the frequency and duration of close contact among people to slow transmission of infection (social distancing), recommending hygiene measures, and advising the use of personal protective equipment in certain situations. HHS has developed a number of guidances to assist government agencies, businesses, community organizations, and the public in their preparedness efforts, utilizing these strategies. The three guidance documents available for public comment are part of this series and should be reviewed as part of an overall approach to pandemic preparedness. With this notice, the USG requests comment from the public and interested stakeholders on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The text of these draft guidances is available in HTML and PDF formats through the HHS Web site at https:// aspe.hhs.gov/panflu/antiviral-nmasks.htm and the PandemicFlu.Gov Web site at https:// www.pandemicflu.gov. For those who may not have Internet access, a hard copy can be requested from the point of contact, Ms. Julie Schafer, Office of the Assistant Secretary for Preparedness and Response, (202) 205–2882. Dated: May 23, 2008. W. Craig Vanderwagen, Assistant Secretary for Preparedness and Response. [FR Doc. E8–12357 Filed 6–2–08; 8:45 am] BILLING CODE 4151–04–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Surgeon General’s Conference on the Prevention of Preterm Birth Department of Health and Human Services, Office of the Secretary. ACTION: Notice. ebenthall on PRODPC60 with NOTICES AGENCY: SUMMARY: The Surgeon General’s Office, in conjunction with the National Institutes of Health, is hosting a VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 conference titled: Surgeon General’s Conference on the Prevention of Preterm Birth. The conference is open to the public. The conference will be held on June 17, 2008 from 8 a.m. until 6 p.m. ADDRESSES: Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Rockville, Maryland 20852; (301) 822–9200. FOR FURTHER INFORMATION CONTACT: Dr. Michele Kiely, Office of the Surgeon General, Department of Health and Human Services, Room 18–66, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–0448, Michele.Kiely@hhs.gov. DATES: Preterm birth (PTB) remains one of the most complicated research and public health problems in obstetrics and pediatrics. Nearly 12 percent of all babies in the United States are born preterm, and this rate continues to rise. To underscore the importance of the problem, the United States Congress passed Public Law 109–450, the Prematurity Research Expansion and Education for Mothers Who Deliver Infants Early Act (PREEMIE Act). The Secretary of Health and Human Services, acting through the Surgeon General of the U.S. Public Health Service, shall convene a conference to address the growing epidemic of preterm birth. The purpose of the conference will be to: 1. Increase awareness of preterm birth as a serious, common, and costly public health problem; 2. Review the findings and reports issued by the Interagency Coordinating Council, key stakeholders, and any other relevant entities; and, 3. Establish an agenda for activities in both the public and private sectors to address the identification of, treatments for, causes of, and risk factors for preterm labor and delivery. The Office of the Surgeon General, in partnership with public and private organizations, identified selected experts and community leaders from the research, public health, and medical communities committed to preventing preterm birth. Six (6) workgroups will be charged with reviewing the available published literature in advance of the conference, including recommendations from the Institute of Medicine report on Preterm Birth and emerging literature concerning activities needed to help prevent preterm birth. The workgroups will focus on specific key areas with the goal of establishing a national agenda and action plan for both the public and SUPPLEMENTARY INFORMATION: PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 31691 private sectors to address the identification of, treatments for, causes of, and risk factors for preterm labor and delivery. Each workgroup will be challenged to determine what action steps need to be taken to translate what we know into what needs to be done. The workgroups will also outline plans for future research to obtain answers to unresolved questions. The work groups will focus on the key areas of (1) Biomedical Research, (2) Epidemiological Research, (3) Psychosocial and Behavioral Contributors to Preterm Birth, (4) Professional Education and Training, (5) Public Communication and Outreach, and (6) Quality of Care and Health Services. On Tuesday, June 17, the work groups will present a statement of their collective assessment and a proposed national agenda to a general audience. Information useful in developing future strategies to address this public health concern will be presented in the final session of the conference. Advance information about the conference and registration materials can be found at https:// www.surgeongeneral.gov/ under Features. Click on Surgeon General’s Conference on Preventing Preterm Birth, June 16–17, 2008. Public attendance is limited to June 17, 2008 on a spaceavailable basis. Pre-registration at the conference Web site is recommended. If space is available on the date of the conference, registration will be available at the door beginning at 7 a.m. Members of the public will have an opportunity to provide comments at the conference. Public comments will be limited to three minutes per speaker. Materials will be made available at the Web site several weeks before the meeting. Any members of the public who wish to share their views with the work groups before sessions begin can do so at the Web site prior to close of business on June 9, 2008. Additionally, the event will be live video/Webcast and can be viewed during the conference at https://videocast.nih.gov. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Dated: May 28, 2008. Steven K. Galson, RADM, USPHS, Acting Surgeon General. [FR Doc. E8–12341 Filed 6–2–08; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31690-31691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12357]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Availability of Draft Guidances To Assist in 
Preparation for an Influenza Pandemic

AGENCY: Office of the Secretary, Health and Human Services.

ACTION: Notice of Availability.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) is seeking 
public comment on three draft guidances: Interim Guidance on the Use 
and Purchase of Facemasks and Respirators by Individuals and Families 
for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral 
Drug Use during an Influenza Pandemic; and Proposed Considerations for 
Antiviral Drug Stockpiling by Employers In Preparation for an Influenza 
Pandemic. The draft Guidances are now available on the HHS Web site 
https://aspe.hhs.gov/panflu/antiviral-n-masks.htm

DATES: Submit comments on or before July 3, 2008.

ADDRESSES: Instructions for Submitting Comments: Electronic responses 
are preferred. Comments on the Facemask and Respirator guidance may be 
addressed to Panflucomments1@hhs.gov. Comments on the Antiviral Use 
guidance may be addressed to Panflucomments2@hhs.gov. Comments on the 
Employer Antiviral Stockpiling guidance may be addressed to 
Panflucomments3@hhs.gov. Written responses should be addressed to U.S. 
Department of Health and Human Services, Room 434E, 200 Independence 
Avenue, SW., Washington, DC 20201, Attention: Pandemic Influenza Masks 
Comments, Attention: Pandemic Influenza Antiviral Comments, or 
Attention: Pandemic Influenza Employer Antiviral Comments, 
respectively. A copy of this Notice and the full text of the draft 
Guidances are available on the HHS Web site at https://aspe.hhs.gov/
panflu/antiviral-n-masks.htm and the PandemicFlu.Gov Web site at http:/
/www.pandemicflu.gov. Please follow instructions for submitting 
responses.
    The submission of comments in response to this notice should not 
exceed 25 pages for each guidance, not including appendices and 
supplemental documents. Any information you submit will be made public. 
Consequently, please do not send any proprietary, commercial, 
financial, business confidential, trade secret, or personal information 
that you do not wish to be made public.
    Public Access: Responses to this notice will be available to the 
public in the HHS Public Reading Room, 200 Independence Avenue, SW., 
Washington, DC 20201. Please call (202) 690-7453 between 9 a.m. and 5 
p.m. to arrange access.

FOR FURTHER INFORMATION CONTACT: Ms. Julie Schafer, Office of the 
Assistant Secretary for Preparedness and Response, (202) 205-2882.

SUPPLEMENTARY INFORMATION: Influenza viruses have threatened the health 
of animal and human populations for centuries. A pandemic occurs when a 
novel strain of influenza virus emerges that has the ability to infect 
and be easily passed between humans. Because humans have little 
immunity to the new virus, many people may become ill and a worldwide 
epidemic, or pandemic, can ensue. Three human influenza pandemics 
occurred in the 20th century. In the United States (US) each pandemic 
led to illness in approximately 30 percent of the population and death 
in between 2 in 100 and 2 in 1000 of those infected. It is projected 
that based on this historical experience and given the current U.S. 
population, a pandemic today, absent effective control measures, could 
result in the deaths of 200,000 to 2 million people in the U.S. alone.
    The U.S. Government (USG) has developed a comprehensive strategy to 
prepare for and respond to an influenza pandemic, including developing 
and

[[Page 31691]]

acquiring vaccine and antivirals to prevent and treat illness, planning 
for use of measures to reduce the spread of the disease by asking ill 
persons to stay home, voluntary quarantine of household members who 
live with an ill person, closure of child care facilities and dismissal 
of students from schools, decreasing the frequency and duration of 
close contact among people to slow transmission of infection (social 
distancing), recommending hygiene measures, and advising the use of 
personal protective equipment in certain situations. HHS has developed 
a number of guidances to assist government agencies, businesses, 
community organizations, and the public in their preparedness efforts, 
utilizing these strategies. The three guidance documents available for 
public comment are part of this series and should be reviewed as part 
of an overall approach to pandemic preparedness.
    With this notice, the USG requests comment from the public and 
interested stakeholders on three draft guidances: Interim Guidance on 
the Use and Purchase of Facemasks and Respirators by Individuals and 
Families for Pandemic Influenza Preparedness; Proposed Guidance on 
Antiviral Drug Use during an Influenza Pandemic; and Proposed 
Considerations for Antiviral Drug Stockpiling by Employers In 
Preparation for an Influenza Pandemic. The text of these draft 
guidances is available in HTML and PDF formats through the HHS Web site 
at https://aspe.hhs.gov/panflu/antiviral-n-masks.htm and the 
PandemicFlu.Gov Web site at https://www.pandemicflu.gov. For those who 
may not have Internet access, a hard copy can be requested from the 
point of contact, Ms. Julie Schafer, Office of the Assistant Secretary 
for Preparedness and Response, (202) 205-2882.

    Dated: May 23, 2008.
W. Craig Vanderwagen,
Assistant Secretary for Preparedness and Response.
 [FR Doc. E8-12357 Filed 6-2-08; 8:45 am]
BILLING CODE 4151-04-P
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