Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 44855 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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. 

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 

the Internet at http://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 

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 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. 

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 

Hours per 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; 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
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) 

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 

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 http:// 

www.workplace.samhsa.gov and http:// 

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 

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– 


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