Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative, 44855-44856 [E9-20882]
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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]
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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]
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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.
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
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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]
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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