Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative, 44855-44856 [E9-20882]

Download as PDF Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices Dated: August 3, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–20967 Filed 8–28–09; 8:45 am] BILLING CODE 4163–18–P the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: August 21, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–20895 Filed 8–28–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Institutes of Health [Docket No. FDA–2008–N–0565] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level AGENCY: Food and Drug Administration, HHS. ACTION: Notice. cprice-sewell on DSK2BSOYB1PROD with NOTICES SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301– 796–3792. SUPPLEMENTARY INFORMATION: In the Federal Register of April 28, 2009 (74 FR 19225), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0396. The approval expires on August 31, 2012. A copy of the supporting statement for this information collection is available on Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Evaluation of the NIAID HIV Vaccine Research Education Initiative, Highly Impacted Population Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: Developing measures that protect against HIV infection is one of NIAID’s highest priorities. Methods in development for the prevention of HIV infection include: HIV vaccines, microbicides, and preexposure prophylaxis (PrEP). Given the daunting complexity of the HIV virus, developing these methods will ultimately require tens of thousands of volunteers to participate in HIV prevention clinical trials. In the U.S., minority participation in clinical trials of HIV prevention technologies is essential; nearly two-thirds of people diagnosed with HIV in the United States are African American or Hispanic/ Latino. Historically, recruitment of racial/ethnic populations has been a critical challenge for medical researchers, and initiatives to increase recruitment of these groups into cancer and chronic disease trials have only been partially successful. 44855 To address the need for volunteers in HIV vaccine clinical trials, and enable NIAID to fulfill its Congressional mandate to prevent infectious diseases like HIV/AIDS, NIAID created the NIAID HIV Vaccine Research Education Initiative (NHVREI). The goal of NHVREI is to increase knowledge about and support for HIV vaccine research among U.S. populations most heavily affected by HIV/AIDS—in particular, African Americans, Hispanics/Latinos, men who have sex with men (MSM), women and youth, recognizing the intersection of these groups. A critical component of NHVREI is outreach to members of these specific highly impacted populations. With the assistance of funded community-based and national organizations, NHVREI is designing, developing, and disseminating HIV vaccine researchrelated messages to NHVREI target audiences. These messages are delivered through print (e.g., brochures, posters, fact sheets, information kits), radio, TV, and Internet resources. Print materials are distributed through various NHVREI program activities (e.g., trainings, conferences, symposia) and other NIAID-funded partners, governmental and non-governmental organizations. NIAID is conducting an evaluation of the NHVREI program in order to assess its impact and generate key findings applicable toward the design of future educational initiatives. Part of the evaluation includes a population survey to guide future NHVREI activities. With this document, NIAID requests clearance for the third part of the evaluation, a survey of the general population and members of the U.S. populations most heavily impacted by HIV/AIDS. The survey will be conducted once in 2010. The total number of respondent burden hours will not exceed 1167 annually. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: General U.S. population with oversampling of subpopulations highly impacted by HIV. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Total No. of respondents Highly Impacted Population Surveys ........................................................................................... Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited VerDate Nov<24>2008 14:57 Aug 28, 2009 Jkt 217001 on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Hours per response Total hours 3,500 0.33333 1,167 performance of the function of the agency, including whether the information will have practical utility; E:\FR\FM\31AUN1.SGM 31AUN1 44856 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Katharine Kripke, Assistant Director, Vaccine Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr., Bethesda, MD 20892–7628, or call non-toll-free number 301–402–0846, or E-mail your request, including your address to NIAIDsurvey@NIH.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: August 25, 2009. J.J. McGowan, Executive Officer, NIAID, National Institutes of Health. [FR Doc. E9–20882 Filed 8–28–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) cprice-sewell on DSK2BSOYB1PROD with NOTICES Advisory Board on Radiation and Worker Health: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Advisory Board on Radiation and Worker Health, Department of Health and Human Services, has been renewed for a 2-year period through August 3, 2011. For information, contact Mr. Theodore Katz, Executive Secretary, Advisory Board on Radiation and Worker Health, Department of Health and Human Services, 1600 Clifton Road, M/S E20, Atlanta, Georgia, 30341, telephone 404/498–2533, or fax 404/ 498–2570. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of VerDate Nov<24>2008 14:57 Aug 28, 2009 Jkt 217001 meetings and other committee management activities, for both the CDC and the Agency for Toxic Substances and Disease Registry. Dated: August 19, 2009. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–20958 Filed 8–28–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https:// www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, Room 2– 1042, One Choke Cherry Road, Rockville, Maryland 20857; 240–276– 2600 (voice), 240–276–2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 in accordance with Executive Order 12564 and section 503 of Public Law 100–71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227. 414–328–7840/800– 877–7016. (Formerly: Bayshore Clinical Laboratory.) ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624. 585–429–2264. Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118. 901–794–5770/888–290–1150. Aegis Analytical Laboratories, 345 Hill Ave., Nashville, TN 37210. 615–255–2400. (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc.) Baptist Medical Center-Toxicology Laboratory, 9601 I–630, Exit 7, Little Rock, AR 72205–7299. 501–202–2783. (Formerly: Forensic Toxicology Laboratory Baptist Medical Center.) Clendo Reference Laboratory, Avenue Santa Cruz #58, Bayamon, Puerto Rico 00959. 787–620–9095. Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215–2802. 800–445–6917. Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602. 229–671–2281. DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974. 215–674– 9310. DynaLIFE Dx,* 10150–102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2. 780– 451–3702/800–661–9876. (Formerly: Dynacare Kasper Medical Laboratories.) ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655. 662–236–2609. Gamma-Dynacare Medical Laboratories,* A Division of the Gamma-Dynacare Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4. 519–679–1630. Kroll Laboratory Specialists, Inc., 1111 Newton St., Gretna, LA 70053. 504–361– E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44855-44856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20882]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Evaluation of the NIAID HIV 
Vaccine Research Education Initiative

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Institute of Allergy 
and Infectious Diseases (NIAID), the National Institutes of Health 
(NIH) will publish periodic summaries of proposed projects to be 
submitted to the Office of Management and Budget (OMB) for review and 
approval.
    Proposed Collection: Title: Evaluation of the NIAID HIV Vaccine 
Research Education Initiative, Highly Impacted Population Survey. Type 
of Information Collection Request: NEW. Need and Use of Information 
Collection: Developing measures that protect against HIV infection is 
one of NIAID's highest priorities. Methods in development for the 
prevention of HIV infection include: HIV vaccines, microbicides, and 
pre-exposure prophylaxis (PrEP). Given the daunting complexity of the 
HIV virus, developing these methods will ultimately require tens of 
thousands of volunteers to participate in HIV prevention clinical 
trials. In the U.S., minority participation in clinical trials of HIV 
prevention technologies is essential; nearly two-thirds of people 
diagnosed with HIV in the United States are African American or 
Hispanic/Latino. Historically, recruitment of racial/ethnic populations 
has been a critical challenge for medical researchers, and initiatives 
to increase recruitment of these groups into cancer and chronic disease 
trials have only been partially successful.
    To address the need for volunteers in HIV vaccine clinical trials, 
and enable NIAID to fulfill its Congressional mandate to prevent 
infectious diseases like HIV/AIDS, NIAID created the NIAID HIV Vaccine 
Research Education Initiative (NHVREI). The goal of NHVREI is to 
increase knowledge about and support for HIV vaccine research among 
U.S. populations most heavily affected by HIV/AIDS--in particular, 
African Americans, Hispanics/Latinos, men who have sex with men (MSM), 
women and youth, recognizing the intersection of these groups.
    A critical component of NHVREI is outreach to members of these 
specific highly impacted populations. With the assistance of funded 
community-based and national organizations, NHVREI is designing, 
developing, and disseminating HIV vaccine research-related messages to 
NHVREI target audiences. These messages are delivered through print 
(e.g., brochures, posters, fact sheets, information kits), radio, TV, 
and Internet resources. Print materials are distributed through various 
NHVREI program activities (e.g., trainings, conferences, symposia) and 
other NIAID-funded partners, governmental and non-governmental 
organizations.
    NIAID is conducting an evaluation of the NHVREI program in order to 
assess its impact and generate key findings applicable toward the 
design of future educational initiatives. Part of the evaluation 
includes a population survey to guide future NHVREI activities.
    With this document, NIAID requests clearance for the third part of 
the evaluation, a survey of the general population and members of the 
U.S. populations most heavily impacted by HIV/AIDS. The survey will be 
conducted once in 2010. The total number of respondent burden hours 
will not exceed 1167 annually. Frequency of Response: Once. Affected 
Public: Individuals. Type of Respondents: General U.S. population with 
oversampling of subpopulations highly impacted by HIV. The annual 
reporting burden is shown in the table below. There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

----------------------------------------------------------------------------------------------------------------
                                                                 Total No. of      Hours per
                                                                 respondents        response       Total hours
----------------------------------------------------------------------------------------------------------------
Highly Impacted Population Surveys...........................           3,500          0.33333            1,167
----------------------------------------------------------------------------------------------------------------

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility;

[[Page 44856]]

(2) The accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) Ways to minimize 
the burden of the collection of information on those who are to 
respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Katharine Kripke, Assistant Director, Vaccine 
Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr., 
Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or 
E-mail your request, including your address to NIAIDsurvey@NIH.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: August 25, 2009.
J.J. McGowan,
Executive Officer, NIAID, National Institutes of Health.
[FR Doc. E9-20882 Filed 8-28-09; 8:45 am]
BILLING CODE 4140-01-P
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