28866 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices 

treatment in accordance with these 

standards as a basis for CSAT 

certification. These standards address 

patient admission requirements, 

medical and counseling services, drug 

testing, and other requirements. The 

final rule also established an 

accreditation requirement. Each OTP is 

required to obtain and maintain 

accreditation from an accreditation 

organization approved by SAMHSA 

under 42 CFR part 8. Accreditation 

organizations that provide OTP 

accreditation under the final rule are 

required to apply for and obtain 

SAMHSA approval. Under 42 CFR 

8.3(a)(3), each accreditation 

organization must develop a set of 

accreditation elements or standards 

together with a detailed discussion of 

how these elements will assure that 

each OTP surveyed by the accreditation 

organization is meeting each of the 

Federal opioid treatment standards. The 

Federal Guidelines for Opioid 

Treatment are intended to guide 

accreditation organizations in preparing 

their accreditation standards. In 

addition, the Guidelines provide useful 

elaborations on the regulatory standards 

set forth under 42 CFR part 8. 

As such, the updated guidelines will 

assist both accreditation organizations 

and OTPs in complying with regulatory 

requirements. Prepared initially in 1997, 

the Federal Opioid Treatment 

Guidelines, originally titled Guidelines 

for the Accreditation of Opioid 

Treatment Programs, are being updated 

to reflect new information and research 

in the field of opioid assisted treatment. 

CSAT convened an expert panel to 

provide the draft guideline now being 

circulated for comment. CSAT is 

soliciting comments on the guideline 

from the public, and expects comments 

from OTPs, accreditation organizations, 

patients, the medical community and 

other interested parties. All comments 

submitted no later than 60 calendar 

days from the date of publication in the 

Federal Register will be considered. 

Summer King, 

Statistician. 

[FR Doc. 2013–11637 Filed 5–15–13; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2013–0036] 

Cooperative Research and 

Development Agreement (CRADA) 

Opportunity With the Department of 

Homeland Security for the 

Development of a Foot-and-Mouth 

Disease 3ABC ELISA Diagnostic Kit 

AGENCY: Science and Technology 

Directorate, Plum Island Animal Disease 

Center, Department of Homeland 

Security. 

ACTION: Notice of intent. 

SUMMARY: The Department of Homeland 

Security Science and Technology 

Directorate (DHS S&T), through its Plum 

Island Animal Disease Center (PIADC), 

is seeking industry collaborators to aid 

DHS S&T in developing an ELISA 

diagnostic test that it capable of 

obtaining a U.S. regulatory license to 

detect antibodies to at least one of the 

Foot and Mouth Disease virus (FMDV) 

non-structural proteins (NSP): 3A, 3B, 

or 3C. This new FMDV 3ABC ELISA 

may be used in the event of a real or 

suspected outbreak of Foot-and-Mouth 

Disease (FMD) in order to differentiate 

infected from vaccinated, non-infected 

animals (DIVA). 

The role of the industry 

collaborator(s) in this CRADA will be to 

develop and validate the FMDV 3ABC 

ELISA assay in collaboration with DHS 

S&T and the United States Department 

of Agriculture Animal and Plant Health 

Inspection Service Foreign Animal 

Disease Diagnostic Laboratory (USDA 

APHIS FADDL) at PIADC, and with 

other U.S. laboratories that are 

associated with USDA, such as the 

National Animal Health Laboratory 

Network (NAHLN). Components of a 

prototype assay, developed by USDA, 

Texas Veterinary Medical Diagnostic 

Laboratory, and a 3rd party fee-forservice contractor, will be made 

available to the industry collaborator(s). 

The goal of the CRADA is to submit a 

data package to USDA APHIS Center for 

Veterinary Biologics (CVB) in order to 

obtain a U.S. regulatory license for use 

under the direction of USDA 

administrators of the FMDV 3ABC 

ELISA in the U.S. (See CVB Veterinary 

Services Memorandum No. 800.73 for 

‘‘General Requirements for 

Immunodiagnostic Test Kits for the 

Detection of Antibody or Antigen.’’) The 

assay must also successfully identify 

and test a reference panel of sera 

provided by OIE (World Organisation 

for Animal Health) as tested in a U.S. 

Reference Laboratory, e.g., USDA APHIS 

FADDL. 

DHS S&T is seeking CRADA 

collaborators that own or have access to 

the technological components for, have 

the technological expertise in, and have 

proven track records of success in the 

fields of diagnostic test kit research, 

development, and the obtaining of 

USDA licensure for the detection of 

antibodies to viral antigen(s). CRADA 

collaborators must indicate if they are 

currently or may be funded by the 

Federal government, and, if yes, they 

must include a discussion of how 

proposed CRADA work and Federal 

government-funded work would not be 

duplicative. 

The proposed term of the CRADA can 

be up to thirty (30) months. 

DATES: Submit comments on or before 

June 17, 2013. 

ADDRESSES: Mail comments and 

requests to participate to Dr. Angela 

Ervin, (ATTN: Angela Ervin, 245 

Murray Lane SW., Washington, DC 

20528–0075). Submit electronic 

comments and other data to 

Angela.Ervin@hq.dhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Information on DHS CRADAs: 

Marlene Owens, (202) 254–6671. 

SUPPLEMENTARY INFORMATION:

Assay Requirements 

1. Ideally a competitive ELISA (an 

assay in which a molecule in the test 

sample competes against a reagent 

provided in the kit for binding to the 

target) for FMDV NSPs that will 

differentiate FMDV infected from FMDV 

vaccinated animals (DIVA) (specifically 

cattle) and can be made commercially 

by the CRADA partner or by another 

entity and upon request by USDA 

APHIS, be supplied to USDA APHIS 

FADDL and accredited state laboratories 

within the National Animal Health 

Laboratory Network. 

2. The ideal assay will have the 

following characteristics: 

a. Diagnostic sensitivity of at least 

96% for all seven major serotypes of 

FMDV, including detection of cattle 

antibodies to FMDV within 7 to 10 days 

post-infection. 

b. Diagnostic specificity of at least 

96%, ideally >99% with respect to 

viruses that cause FMDV look-alike 

clinical signs, such as Vesicular 

Stomatitis Virus, Swine Vesicular 

Disease Virus, Bovine Rhinovirus, 

Seneca Valley Virus. 

c. Compatibility with serum samples 

from U.S. national cattle (beef and 

dairy) and domestic swine herds, and 

ideally with other species that are 

susceptible to FMDV, e.g., sheep, goats, 

feral swine, buffalo, deer, antelope, etc. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices 28867 

d. Assay time not exceeding 4 hours 

from start of incubation to beginning of 

reading the plate. 

e. 96 well modular format. 

f. Positive control (produced from 

non-FMDV infected animals, e.g., 

hyperimmunized with synthetically 

made FMDV peptides/proteins) and 

negative control (produced from naı ̈ve 

animals) for each plate. 

g. Compatibility with Biosafety Level 

2 (BSL–2) laboratory requirements, i.e., 

will not contain any reagents considered 

to be select agents or potentially 

contaminated with select agents. 

3. Transportability under cold chain 

(1) to USDA APHIS PIADC, (2) upon 

USDA APHIS administrator request 

approved laboratories within the 

National Animal Health Laboratory 

network, and (3) outside of the US 

without special restrictions. 

DHS S&T Role (includes but not limited 

to) 

1. As necessary, coordination of 

development and commercialization 

access to critical assay components such 

as the recombinant 3ABC* protein 

(* indicates that the 3C protein has a 

mutation in the active site) and a 

FMDV-specific monoclonal antibody, 

which may be negotiated through 

intellectual property licenses with 3rd 

parties who control rights to these assay 

components. DHS will supply data from 

testing a prototype assay, but DHS will 

not supply historical background or any 

proprietary information. 

2. Coordination of testing and 

evaluation of samples from U.S. cattle 

and swine vaccinated with FMD 

molecular vaccines. 

3. Coordination of testing and 

evaluation of true positive samples from 

U.S. cattle and swine that were 

experimentally infected. A maximum of 

500 samples can be tested. 

4. If requested, coordination of testing 

and evaluation of true positive and true 

negative samples from other FMDV 

susceptible U.S. domestic species. 

5. If requested, coordination of testing 

and evaluation of serum samples from 

FMDV susceptible U.S. wildlife species. 

6. The actual testing of samples listed 

above mainly by scientists in USDA 

APHIS FADDL or by partners in 

laboratories that USDA APHIS FADDL 

and DHS S&T will identify, e.g., the 

NAHLN. 

Period of Performance 

If CRADA collaborator(s) is (are) 

selected, a comprehensive data package 

to obtain a USDA license for the FMDV 

3ABC ELISA for use in cattle should be 

submitted to USDA APHIS CVB within 

30 months of the CRADA award date. 

The submission must adhere to the 

requirements in USDA APHIS CVB 

Veterinary Services Memo No. 800.73 

and other applicable CVB 9CFR 

requirements for diagnostic kits and 

reagents. The assay must also 

successfully identify samples in a 

reference panel of sera provided by OIE 

(World Organisation for Animal Health) 

as tested in a U.S. reference laboratory, 

e.g., USDA APHIS FADDL. Because 

these reference panels are provided on 

a yearly basis to FMD world reference 

laboratories, the testing and analysis of 

results may extend beyond the 30 

month Period of Performance. 

Nevertheless, results should be made 

available within 2 months of the 

availability of reference panels. 

Selection Criteria 

The Plum Island Animal Disease 

Center (PIADC) reserves the right to 

select CRADA collaborators for all, 

some, or none of the proposals in 

response to this notice. PIADC will 

provide no funding for reimbursement 

of proposal development costs. 

Proposals (or any other material) 

submitted in response to this notice will 

not be returned. Proposals submitted are 

expected to be unclassified. 

PIADC will select proposals at its sole 

discretion on the basis of: 

1. How well the proposal 

communicates the collaborators’ 

understanding of and ability to meet the 

CRADAs goals and proposed timeline. 

2. How well the proposal addresses 

the following criteria: 

a. Capability of the collaborator to 

provide equipment and materials for 

proposed testing. 

b. Capability of the collaborator to 

meet the requirements for development, 

validation testing and analysis, and 

submission of supporting data and 

documents fulfilling the CVB 

requirements for licensure in the U.S. 

c. Preliminary data or results which 

support the assay requirements outlined 

above. 

Participation in this CRADA does not 

imply the future purchase of any 

materials, equipment, or services from 

the collaborating entities, and nonFederal CRADA participants will not be 

excluded from any future PIADC 

procurements based solely on their 

participation in this CRADA. 

Authority: CRADAs are authorized by the 

Federal Technology Transfer Act of 1986, as 

amended and codified by 15 U.S.C. 3710a. 

DHS, as an executive agency under 5 U.S.C. 

105, is a Federal agency for the purposes of 

15 U.S.C. 3710a and may enter into a 

CRADA. DHS delegated the authority to 

conduct CRADAs to the Science and 

Technology Directorate and its laboratories. 

Dated: May 9, 2013. 

James Johnson, 

Director, Office of National Laboratories. 

[FR Doc. 2013–11693 Filed 5–15–13; 8:45 am] 

BILLING CODE 9110–9F–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2013–0078] 

Privacy Act of 1974; Department of 

Homeland Security/U.S. Immigration 

and Customs Enforcement—014 

Homeland Security Investigations 

Forensic Laboratory System of 

Records 

AGENCY: Privacy Office, Department of 

Homeland Security. 

ACTION: Notice of Privacy Act System of 

Records. 

SUMMARY: In accordance with the 

Privacy Act of 1974, the Department of 

Homeland Security proposes to 

establish a new Department of 

Homeland Security system of records 

titled, ‘‘Department of Homeland 

Security/U.S. Immigration and Customs 

Enforcement—014 Homeland Security 

Investigations Forensic Laboratory 

System of Records.’’ This system of 

records allows the Department of 

Homeland Security/U.S. Immigration 

and Customs Enforcement to collect and 

maintain records by the Homeland 

Security Investigations Forensic 

Laboratory (HSI–FL). The HSI–FL is a 

U.S. crime laboratory specializing in 

scientific authentication; forensic 

examination; research, analysis, and 

training related to travel and identity 

documents; latent and patent finger and 

palm prints; and audio and video files 

in support of law enforcement 

investigations and activities by DHS and 

other agencies. To facilitate forensic 

examinations and for use in forensic 

document training, research, and 

analysis, the HSI–FL maintains case 

files, a case management system, an 

electronic library of travel and identity 

documents (Imaged Documents and 

Exemplars Library), and a hard copy 

library referred to as the HSI–FL 

Library. Additionally, the Department of 

Homeland Security is issuing a Notice 

of Proposed Rulemaking elsewhere in 

the Federal Register to exempt this 

system of records from certain 

provisions of the Privacy Act. This 

newly established system will be 

included in the Department of 

Homeland Security’s inventory of 

record systems. 


tkelley on DSK3SPTVN1PROD with NOTICES