19566 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Treating and Preventing 

Inflammatory Bowel Disease (IBD) 

Involving Interleukin-13 (IL–13) and 

Natural Killer T (NKT) Cells 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

Part 404.7(a)(1)(i), that the National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to practice the inventions 

embodied in PCT Patent Application 

No. PCT/US02/18790, filed June 14, 

2002, which published as WO 2004/ 

001655 on December 31, 2003, now 

expired, entitled ‘‘Method of Treating 

and Preventing Colitis Involving IL–13 

and NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–PCT–01];U.S. Patent 

Application No. 10/517,898, filed 

December 13, 2004, which was 

published as US–2006–0024306 A1 on 

February 2, 2006, entitled ‘‘A Method of 

Treating Inflammatory Bowel Disease 

(IBD)’’ [HHS Ref. No. E–131–2002/0– 

US–02]; European Patent Application 

No. 02742057.9, filed June 14, 2002, 

which published as 1552462 on July 13, 

2005, entitled ‘‘Method of Treating and 

Preventing Colitis Involving IL–13 and 

NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–EP–08]; Australian Patent 

Application No. 2002315115, filed June 

14, 2002, entitled ‘‘Method of Treating 

and Preventing Colitis Involving IL–13 

and NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–AU–05]; Japanese Patent 

Application No. 2004515561, filed June 

14, 2002, entitled ‘‘Method of Treating 

and Preventing Colitis Involving IL–13 

and NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–JP–04]; New Zealand Patent 

Application No. 537726, filed June 14, 

2002, entitled ‘‘Method of Treating and 

Preventing Colitis Involving IL–13 and 

NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–NZ–06]; Hong Kong Patent 

Application No. 05112119.6, filed June 

14, 2002, entitled ‘‘Method of Treating 

and Preventing Colitis Involving IL–13 

and NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–HK–09]; South African Patent 

Application No. 2005/00375, filed June 

14, 2002, entitled ‘‘Method of Treating 

and Preventing Colitis Involving IL–13 

and NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–ZA–07]; Canadian Patent 

Application No. 2489540, filed June 14, 

2002, entitled ‘‘Method of Treating and 

Preventing Colitis Involving IL–13 and 

NK–T Cells’’ [HHS Ref. No. E–131– 

2002/0–CA–03]; U.S. Provisional Patent 

Application No. 60/671,624, filed April 

15, 2005, now abandoned, entitled 

‘‘Treatment and prevention of IBD using 

Mutant and Chimeric IL–13 Molecules’’ 

[HHS Ref. No. E–003–2005/0–US–01]; 

PCT Patent Application No. PCT/US06/ 

014393, filed April 14, 2006, now 

expired, entitled ‘‘Methods of Treating 

and Preventing Inflammatory Bowel 

Disease Involving IL–13 and NKT 

Cells,’’ which published as WO 2006/ 

113614 on October 20, 2006 [HHS Ref. 

No. E–003–2005/0–PCT–02]; European 

Patent Application No. 06750435.7, 

filed November 12, 2007, entitled 

‘‘Methods of Treating and Preventing 

Inflammatory Bowel Disease Involving 

IL–13 and NKT Cells,’’ which published 

as 1877074 on January 16, 2008, [HHS 

Ref. No. E–003–2005/0–EP–04]; and 

U.S. Patent Application No. 11/918,711, 

filed April 14, 2006, entitled ‘‘Treatment 

and Prevention of Inflammatory Bowel 

Disease (IBD) Using Mutant and 

Chimeric IL–13 Molecules’’ [HHS Ref. 

No. E–003–2005/0–US–03] to Innate 

Immune, Inc. which has an office in 

Stanford, California, U.S.A. The patent 

rights in these inventions have been 

assigned to the United States of America 

and Brigham and Women’s Hospital. 

The prospective exclusive license 

territory may be ‘‘worldwide’’, and the 

field of use may be limited to ‘‘the use 

of agents that modulate Natural Killer T 

cell (NKT cell) activity and/or NKT cell 

number a) by interaction with antigenpresenting cells expressing CD1d family 

of proteins, and/or b) by interaction 

with NKT cell receptors that bind to 

antigen-presenting cells expressing 

CD1d family of proteins, as therapeutics 

for the treatment or prevention of 

inflammatory bowel disease (IBD), 

including ulcerative colitis and Crohn’s 

disease.’’ 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before June 

29, 2009 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Suryanarayana (Sury) 

Vepa, Ph.D., J.D., Licensing and 

Patenting Manager, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 435–5020; Facsimile: 

(301) 402–0220; E-mail: 

vepas@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

subject technology is directed to 

methods of treating inflammatory bowel 

disease (IBD), more specifically 

Ulcerative Colitis (UC). The inventors of 

this technology have used a mouse 

model of experimental colitis (OC) to 

show that Interleukin (IL)-13, a Th2 

cytokine, is a significant pathologic 

factor in OC and that neutralizing IL–13 

in these animals effectively prevents 

colitis (Immunity (2002) 17, 629–638). 

The subject technology provides for 

methods of treating UC by reducing 

NKT cell activity. This reduction in 

NKT cell activity can be accomplished 

by inhibition of the cytokine IL–13 or its 

receptor, IL–13R, or through modulation 

of another NKT cell surface receptor, 

such as the T-cell receptor. The T-cell 

receptor is activated by the 

glycoprotein, CD1d, which is expressed 

on the surface of antigen-presenting 

cells. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless 

within sixty (60) days from the date of 

this published notice, the NIH receives 

written evidence and argument that 

establishes that the grant of the license 

would not be consistent with the 

requirements of 35 U.S.C. 209 and 37 

CFR 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: April 23, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–9856 Filed 4–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Request for Comment on Minimum 

Requirements for Criteria in Grant 

Applications Under the National All 

Schedules Prescription Electronic 

Reporting Act of 2005 (NASPER) 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 


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SUMMARY: This notice is to request 

comments from interested parties 

regarding criteria for grants issued 

under NASPER (42 U.S.C. 280g–3). 

NASPER establishes a formula grant 

program for States to establish or 

improve State controlled substance 

monitoring systems (‘‘prescription 

monitoring programs,’’ or ‘‘PMPs’’). 

Under NASPER, the Secretary will 

award grants to qualifying States, 

defined in the legislation as the 50 

States and the District of Columbia (42 

U.S.C. 280g–3(i)(8)). This notice is 

required under NASPER and comments 

received in response to this notice will 

be evaluated and as appropriate, 

included in public announcements for 

grants under this law. 

SAMHSA will be issuing a Request 

for Applications (RFA) for formula grant 

awards under the NASPER program in 

Federal fiscal year (FFY) 2009. 

Authority: Section 399O, of the Public 

Health Service Act, as amended. 

DATES: The closing date to submit 

comments will be May 29, 2009. The 

Administrator believes that this limited 

comment period is necessary and 

justified to comply with the timelines 

necessary to announce, submit, review 

and award grants before the end of the 

fiscal year, September 30, 2009. 

ADDRESSES: To assure proper handling 

of comments, please reference ‘‘Docket 

No. CSAT 002’’ on all written and 

electronic correspondence. Written 

comments may be submitted to the 

Division of Pharmacologic Therapies, 

Center for Substance Abuse Treatment, 

1 Choke Cherry Road, Room 2–1063, 

Rockville, MD 20857; Attention: DPT 

Federal Register Representative. 

Alternatively, comments may be 

submitted directly to SAMHSA by 

sending an electronic message to 

dpt_interimrule@samhsa.hhs.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the http:// 

www.regulation.gov Web site. SAMHSA 

will accept attachments to electronic 

comments in Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. SAMHSA will not accept 

any file formats other than those 

specifically listed here. 

Please note that SAMHSA is 

requesting that electronic comments be 

submitted before midnight Eastern time 

on the day the comment period closes 

because http://www.regulations.gov 

terminates the public’s ability to submit 

comments at midnight Eastern time on 

the day the comment period closes. 

Commenters in time zones other than 

Eastern time may want to consider this 

so that their electronic comments are 

received. All comments sent via regular 

or express mail will be considered 

timely if postmarked on the day the 

comment period closes. 

Posting of Public Comments: Please 

note that all comments received are 

considered part of the public record and 

made available for public inspection 

Online at http://www.regulations.gov 

and in the SAMHSA’s public docket. 

Such information includes personal 

identifying information (such as your 

name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘Personal Identifying 

Information’’ in the first paragraph of 

your comment. You must also place all 

the personal identifying information 

you do not want posted Online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘Confidential Business 

Information’’ in the first paragraph of 

your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted Online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the SAMHSA’s public docket 

file. Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the ‘‘For 

Further Information’’ paragraph. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Reuter, Center for Substance 

Abuse Treatment (CSAT), Division of 

Pharmacologic Therapies, SAMHSA, 1 

Choke Cherry Road, Room 2–1063, 

Rockville, MD 20857, (240) 276–2716, email: Nicholas.Reuter@samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The National All Schedules 

Prescription Electronic Reporting Act of 

2005, (‘‘NASPER’’ Pub. L. 109–60) 

enacted August 11, 2005, created a 

formula grant program under the 

authority of the Secretary for Health and 

Human Services (‘‘the Secretary’’) for 

State controlled substance monitoring 

systems (‘‘prescription monitoring 

programs,’’ hereinafter, ‘‘PMPs’’). The 

intent of this new law is to foster the 

establishment or enhancement of Stateadministered controlled substance 

monitoring systems in order to ensure 

that health care providers and law 

enforcement officials and other 

regulatory bodies have access to 

accurate, timely prescription history 

information. In addition, the expansion 

and establishment of prescription 

monitoring systems has the potential for 

assisting in the early identification of 

patients at risk for addiction. 

Although NASPER authorized 

funding, an appropriation for NASPER 

was not available until March 11, 2009. 

The Omnibus Spending Act of 2009 

appropriated $2 million to SAMHSA for 

‘‘prescription monitoring programs 

(NASPER)’’ for fiscal year 2009. 

According to the National Alliance of 

Model State Drug Laws (NAMSDL), as 

of February 2009, 32 States have 

operational prescription monitoring 

programs (PMPs). An additional 6 States 

have enacted legislation and 5 States 

have pending legislation to start a PMP. 

Although there is considerable 

variation, the programs essentially 

require that pharmacies, physicians, or 

both, submit information on 

prescriptions dispensed for certain 

controlled substances as mandated by 

State law. Prescriber and patient 

information relating to prescriptions 

issued for controlled stimulants, 

sedatives/depressants, anxiolytics, 

narcotics, etc., is transmitted to a central 

office within each State. 

NASPER establishes the authority for 

a grant program with the Secretary, 

HHS, wherein a State may submit an 

application to implement a new 

controlled substance prescription 

monitoring system, or to make 

improvements upon an existing State 

controlled substance monitoring system. 

In addition, the legislation includes 

provisions for standardization that will 

enable and require the sharing of 

information between States with 

programs. The State application for a 

grant must include measures to prevent 

unauthorized disclosures. This is 

important as State PMPs include 

personal patient health information on 

both individuals who receive and fill 


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controlled substance prescriptions and 

those who have had a controlled 

substance dispensed to them beyond a 

48-hour supply. 

To be eligible to receive a grant under 

NASPER, the State must demonstrate 

that the State has enacted legislation or 

regulations to permit the 

implementation of the State controlled 

substance monitoring program and the 

imposition of appropriate penalties for 

the unauthorized use and disclosure of 

information maintained in such 

program. Additional requirements for 

applications are set forth under 42 

U.S.C. 280g–3(c), and include budget 

cost estimates, interoperability 

standards, uniform electronic formats, 

access to information, penalties for 

unauthorized disclosures and other 

issues. SAMHSA will issue a formal 

request for applications in the next 

several weeks that will specify State 

application requirements. 

II. Request for Comments 

Before awarding grants to States 

under NASPER, the Secretary is 

required, after consultating with States 

and other interested parties, to seek 

public comment on proposed minimum 

requirements. Under 42 U.S.C. 280g– 

3(b), the criteria to be used by States 

relate to the following four purposes: 

1. Criteria for security for information 

handling and for the database 

maintained by the State under 

subsection (e) generally including 

efforts to use appropriate encryption 

technology or other appropriate 

technology to protect the security of 

such information (42 U.S.C. 280g– 

3(c)(1)(A)(ii)); 

2. Criteria for availability of 

information and limitation on access to 

program personnel (42 U.S.C. 280g– 

3)(c)(1)(A)(v)); 

3. Criteria for access to the database, 

and procedures to ensure that 

information in the database is accurate 

(42 U.S.C. 280g–3(c)(1)(A)(vi)); 

4. Criteria for the use and disclosure 

of information, including a description 

of the certification process to be applied 

to requests for information under 

subsection (f) (42 U.S.C. 280g– 

3)(c)(1)(A)(vii)). 

A. Consultation With States and Other 

Interested Parties 

Prescription monitoring programs 

(‘‘PMPs’’) have been in place for 

decades. In addition, the Federal 

Government has supported the 

development, enhancement, and 

expansion of these State programs for 

several years under the ‘‘Harold Rogers 

Prescription Drug Monitoring Grant 

Program,’’ which is administered by the 

Department of Justice, Bureau of Justice 

Assistance (DOJ/BJA). In fiscal year (FY) 

2009, the Harold Rogers Grant Program 

will operate concurrently with the 

NASPER grant program. Since FY 2003, 

BJA has provided training and technical 

assistance to grantees and to States 

which are planning to implement a 

program. BJA training and technical 

assistance partners have included the 

National Alliance for Model State Drug 

Laws, the IJIS Institute, the National 

Conference of State Legislatures, the 

Addiction Technology Transfer Center, 

Brandeis University, and the Alliance of 

States with Prescription Drug 

Monitoring Programs. 

In developing these proposed 

minimum standards, SAMHSA has 

consulted with DOJ/BJA and the 

Alliance of States with Prescription 

Drug Monitoring Programs to obtain 

information about their experience with 

PMP operating requirements. In 

addition, SAMHSA has discussed 

NASPER provisions with individual 

States with PMPs, and entities such as 

the Institute of Justice Information 

Systems, which have provided technical 

assistance to State PMPs on interstate 

information sharing. SAMHSA has 

reviewed the Model State PMP law, the 

Harold Rogers Grant Program grant 

solicitations, as well as numerous 

reports, survey results, and published 

articles in prepared proposed minimum 

requirements. While additional time 

may have permitted a more extensive 

and formal level of consultation, 

SAMHSA believes that taken together, 

the approach outlined above provides a 

sufficient level of consultation for the 

minimum requirements proposed for 

comment in this notice. 

B. Proposed Minimum Requirements 

Overall, the Administrator’s intent in 

proposing the minimum standards 

below is to facilitate the stated goals of 

NASPER—to foster establishment of 

PMPs that provide timely information to 

health care providers and others, and, 

over time, to guide the improvement of 

PMPs with best practices. In addition, 

the Administrator strives with these 

proposed minimum requirements to 

balance the need to advance PMPs with 

what States applying for NASPER grants 

could be realistically expected to 

achieve in a relatively short period of 

time. 

1. Criteria for security for information 

handling and for the database 

maintained by the State under 

subsection (e) generally including 

efforts to use appropriate encryption 

technology or other appropriate 

technology to protect the security of 

such information (42 U.S.C. 280g– 

3(c)(1)(A)(ii)); 

State PMPs include personal patient 

health information on both individuals 

who receive and fill controlled 

substance prescriptions and those who 

have had a controlled substance 

dispensed to them beyond a 48-hour 

supply. In addition, PMPs need to 

collect identification information on 

prescribers and dispensers. Finally, the 

systems need to collect information that 

identifies the types and quantities of the 

prescribed/dispensed substances. The 

information collection requirements 

under NASPER are set forth under 42 

U.S.C. 280g–3(d)(3)(A). 

Information from PMPs must be 

stored and protected in an electronic 

manner that, at a minimum, is at least 

equivalent to the standards set forth in 

regulations promulgated under section 

262 of the Health Insurance Portability 

and Accountability Act of 1996 (Pub. L. 

104–191; 110 Stat. 2033). This would 

include the technical safeguards 

standards of the HIPAA Security Rule 

under 45 CFR 164.312. ‘‘Technical 

safeguards’’ is defined at 45 CFR 

164.304 as, ‘‘the technology and the 

policy and procedures for its use that 

protect electronic protected health 

information and control access to it.’’ 

These HIPAA security regulations 

include technical safeguards for access 

control, audit controls, integrity, person 

or entity authentication, and 

transmission security. The access 

control standards require, at a 

minimum, unique user identification, 

and an emergency access procedure, 

with automatic logoff and encryption/ 

decryption as addressable 

implementation specifications. 

In addition, NASPER does not 

supersede the requirements of the 

Federal substance abuse confidentiality 

law (42 U.S.C. 290dd–2) and regulations 

under 42 CFR part 2. 

The Administrator is proposing as a 

minimum requirement that PMP 

databases are stored on separate servers, 

physically secured with firewall 

protections. These databases must 

provide for backup and restore needs in 

the event of disasters. These back up 

systems must conform to the same 

security requirements. 

As discussed in more detail below, 

information from these electronic 

prescription drug monitoring databases 

is released to certain entities upon 

request (solicited), or without request 

(unsolicited). The transmission of this 

information must also be secure to 

prevent inadvertent disclosure. The 

Administrator understands that many of 

these releases are conducted by webbased applications. At a minimum, the 


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Secretary is proposing to require that 

such web-based releases are encrypted 

with 128-bit Secure Socket Logic 

technology. 

2. Criteria for availability of 

information and limitation on access to 

program personnel (42 U.S.C. 280g– 

3(c)(1)(A)(v)); 

For the purposes of organization, the 

Administrator will address ‘‘criteria for 

availability of information’’ under item 

four, below. ‘‘Limitation on access to 

program personnel’’ will be interpreted 

for the purposes of this notice to mean 

limiting access to individuals within the 

State PMP program to the PMP database 

and the PMP data itself. 

The Administrator is proposing that 

each PMP have a ‘‘Master 

Administrator.’’ The master 

administrator is an individual with the 

responsibility of controlling and 

monitoring access to the PMP database 

itself. This individual has the 

responsibility for assigning usernames 

and passwords to those who are granted 

access to PMP data (both State 

employees and non-State employees 

who are certified to receive PMP data 

notices.) A second key responsibility of 

the master administrator is the ability to 

maintain a log that accurately details 

those who have accessed and received 

data from the PMP database. The 

Administrator is proposing that this log 

requirement would not have to provide 

‘‘per record’’ detail information. In other 

words, the master administrator log 

would need to detail who accessed the 

system when, but not each record 

received. 

3. Criteria for access to the database, 

and procedures to ensure that 

information in the database is accurate 

(42 U.S.C. 280g–3(c)(1)(A)(vi)); 

For the purposes of organization, the 

Administrator will address ‘‘criteria for 

access to the database’’ under sections 

two and four, and proposed minimum 

standards here (section 3) relating to 

procedures to ensure that information in 

the database is accurate. 

Based upon consultations with States 

and other entities, the Administrator 

believes that the procedures applied by 

PMPs to ensure accuracy have evolved 

over the years. Indeed, electronic PMPs 

rely on much of the same technology for 

transmission of prescription drug data 

as that used by the private and public 

insurance systems. As such, these 

electronic data transmission switches 

have evolved procedures and safeguards 

to help assure that the information is 

accurate for reimbursement purposes. 

The Administrator proposes for 

comment the following minimum 

requirements for accuracy. First, PMPs 

must adopt the most recent version of 

the American Society for Automation in 

Pharmacy (ASAP) standard for 

electronic prescription formatting. 

Adoption of the minimum, which the 

Administrator believes is almost 

universally in place will help ensure 

that gross formatting errors in 

identification numbers, NDC codes, etc., 

are minimized. In addition, the 

Administrator is proposing as a 

minimum requirement that PMPs 

applying for NASPER grants must have 

a mechanism for correcting inaccuracies 

when notified by physicians, 

pharmacists, patients, and others. 

4. Criteria for the use and disclosure 

of information, including a description 

of the certification process to be applied 

to requests for information under 

subsection (f) (42 U.S.C. 280g– 

3(c)(1)(A)(vii)). 

The intent of this provision is to limit 

the disclosure of information from a 

State PMP to that necessary for public 

health and law enforcement purposes. 

NASPER envisions two types of 

disclosures from PMPs—solicited 

disclosures and unsolicited disclosures. 

Solicited Disclosure of Information 

from PMP. Under 42 U.S.C. 280g–3(f)(1), 

a State may disclose information from 

the PMP only in response to a request 

(‘‘a solicited request’’) by five entities: 

(a) A practitioner (or the agent thereof), 

(b) any local, State, or Federal law 

enforcement, narcotics control, 

licensure, disciplinary, or program 

authority, (c) the controlled substance 

monitoring program of another State or 

group of States with whom the State has 

established an interoperability 

agreement, (d) any agent of the 

Department of Health and Human 

Services, a State Medicaid program, a 

State health department, or the Drug 

Enforcement Administration, and (e) an 

agent of the State agency or entity of 

another State that is responsible for the 

establishment and maintenance of that 

State’s controlled substance monitoring 

program. The Administrator views 

solicited requests for information as a 

two component process. First, the 

individual or entity requesting 

information from the PMP must be 

authorized (‘‘authentication’’) to receive 

the information. Next, the authorized 

individual or entity must provide a need 

(‘‘certification’’) for the requested 

information. 

The Administrator is proposing 

minimum authentication and 

certification requirements for solicited 

disclosures from PMPs for the five 

entities listed in NASPER. 

(a) A practitioner (or the agent thereof, 

including pharmacist) must submit a 

hard copy written, signed, and notarized 

request to the designated State agency, 

which in turn, verifies the information 

before providing a username and 

password to the practitioner. The 

request must include the practitioner’s 

name and date of birth, a corresponding 

DEA registration number, and State 

medical license number. In soliciting 

information from the State PMP 

database, the practitioner must certify 

that the requested information is for the 

purpose of providing medical or 

pharmaceutical treatment or evaluating 

the need for such treatment to a bona 

fide current patient. The Administrator 

envisions that such requests/ 

certifications can be conducted by webbased procedures. 

(b) A local, State, or Federal law 

enforcement, narcotics control, 

licensure, disciplinary, or program 

authority must submit a hard copy 

written signed and notarized request to 

the designated State agency, which in 

turn, verifies the information before 

providing a username and password to 

the practitioner. The request must 

include the agency name and the 

individuals who will be authorized to 

request access within the agency. The 

requestor must certify for each 

disclosure that the requested 

information is related to an individual 

investigation or proceeding involving 

the unlawful diversion or misuse of a 

schedule II, III, or IV substance, and that 

such information will further the 

purpose of the investigation or assist in 

the proceeding. Such requests shall 

include an active case number or 

provide other assurance that the request 

is pursuant to the law enforcement 

agency’s official duties and 

responsibilities. 

(c) The controlled substance 

monitoring program of another State or 

group of States must have an 

established, signed interoperability 

agreement in place before interstate 

patient information sharing (but not 

anonymous, aggregate data) can 

proceed. The Administrator notes that 

there is considerable activity underway 

between States, including ‘‘pilot 

studies’’ to explore interoperability 

technical and other issues. As such, at 

this time the Administrator is proposing 

that any interoperability agreements that 

meet the requirements of the individual 

State PMPs, and the general 

requirements established by this notice, 

should be acceptable. This means, for 

example, that if the ultimate 

information requestor is a law 

enforcement entity, each State PMP 

must meet the authentication and 

certification requirements proposed 

under (b), above. 

(d) Any agent of the Department of 

Health and Human Services, a State 


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Medicaid program, a State health 

department, or the Drug Enforcement 

Administration must submit a written 

request to the State PMP that identifies 

the summary statistics sought. The 

requesting Department, program, 

administration, etc., must certify that 

the requested information is necessary 

for research to be conducted by such 

department, program, or administration, 

respectively, and the intended purpose 

of the research is related to a function 

committed to such department, 

program, or administration by law that 

is not investigative in nature. 

(e) An agent of the State agency or 

entity of another State that is 

responsible for the establishment and 

maintenance of the State’s controlled 

substance monitoring program must 

submit a written request on Agency 

letterhead that identifies the requestor 

as the person responsible for that State’s 

controlled substance monitoring 

program. After authentication by the 

disclosing State PMP, the requesting 

State certifies that (i) the State has an 

application approved under this section; 

and (ii) the requested information is for 

the purpose of implementing the State’s 

controlled substance monitoring 

program. 

Patients. The Administrator notes that 

NASPER does not specifically designate 

disclosures to patients as a category for 

minimum requirements, perhaps 

because HIPAA and other patient 

information access provisions already 

permit sufficient patient access to their 

own controlled prescription drug 

information. The Administrator invites 

specific comment on this issue. 

Unsolicited Disclosures of 

Information from PMPs. Practitioners 

and Dispensers. Under 42 U.S.C. 280g– 

3(f)(2)(A), NASPER requires that ‘‘[I]n 

consultation with practitioners, 

dispensers, and other relevant and 

interested stakeholders, a State 

receiving a grant under subsection (a) 

* * * shall establish a program to notify 

practitioners and dispensers of 

information that will help identify and 

prevent the unlawful diversion or 

misuse of controlled substances * * *.’’ 

The Administrator understands that 

notifying prescribers and dispensers 

when PMP activity suggest drug 

diversion, or identifying individuals 

who may need substance abuse 

treatment, is important to reducing 

substance abuse and reducing illicit 

distribution of controlled prescription 

substances. In addition, the 

Administrator is aware that many States 

have established ‘‘thresholds’’ that 

trigger such notifications. States have 

considerable latitude in establishing 

such programs; and, at a minimum 

States must establish and articulate the 

criteria for such thresholds. For 

example: The threshold for notifying 

prescribers and dispensers is when an 

individual has filled five or more 

controlled substance prescriptions from 

five different prescribers, or five 

different dispensers in the State, within 

a six month period. 

Drug Diversion Investigators—Under 

42 U.S.C. 280g–3(f)(2)(B) a State PMP 

‘‘may, to the extent permitted under 

State law, notify the appropriate 

authorities responsible for carrying out 

drug diversion investigations if the State 

determines that information in the 

database maintained by the State under 

subsection (e) indicates an unlawful 

diversion or abuse of a controlled 

substance.’’ 

The Administrator notes that the 

language in NASPER clearly indicates 

that the provision for PMP to notify law 

enforcement officials of potentially 

criminal violations is voluntary. It is 

likely that most States with existing 

PMPs have established procedures and 

thresholds for these types of unsolicited 

disclosures. The Administrator 

understands that minimum required 

thresholds and procedures would be 

quantitatively and qualitatively different 

from those proposed for practitioners 

and dispensers, above. At this time, the 

Administrator is not proposing 

minimum requirements for unsolicited 

disclosures to drug diversion 

investigators; however, the 

Administrator invites comment on this 

issue. 

Eric B. Broderick, 

Acting Administrator, Assistant Surgeon 

General, Substance Abuse and Mental Health 

Services Administration. 

[FR Doc. E9–9854 Filed 4–28–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number 105–A] 

Updating the List of Hazardous Drugs 

for the NIOSH Alert: Additions and 

Deletions to the NIOSH Hazardous 

Drug List 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of draft document 

available for public comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) 

announces the availability of the 

following draft document available for 

public comment entitled ‘‘Updating the 

List of Hazardous Drugs for the NIOSH 

Alert: Additions and Deletions to the 

NIOSH Hazardous Drug List.’’ The 

document and instructions for 

submitting comments can be found at 

http://www.cdc.gov/niosh/review/ 

public/105a/. 

DATES: Comments must be postmarked 

by June 30, 2009. 

ADDRESSES: You may submit comments 

to nioshdocket@cdc.gov or to the NIOSH 

Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226 or by 

facsimile (513) 533–8285. Comments 

should be in Microsoft Word format and 

should reference NIOSH docket number 

105–A. NIOSH includes all comments 

received without change in the docket, 

including any personal information 

provided. After the comment period has 

closed, comments will be able to be 

accessed electronically at http:// 

www.cdc.gov/NIOSH under the link to 

the NIOSH docket. As appropriate, 

NIOSH will post comments with the 

commenters’ names, affiliations and 

other information, on the Internet. 

Background: The ‘‘NIOSH Alert: 

Preventing Occupational Exposures to 

Antineoplastic and Other Hazardous 

Drugs in Health Care Settings’’ was 

published in September 2004 (http:// 

www.cdc.gov/niosh/docs/2004–165/). 

Since that time, approximately 60 new 

drugs have received FDA approval and 

approximately 60 drugs have received 

special warnings (usually black box 

warnings) based on reported adverse 

effects in patients. An additional 18 

drugs were included from the updated 

National Institutes of Health (NIH) 

Hazardous Drug List. From this list of 

approximately 150 drugs, 62 drugs were 

determined to have one or more 

characteristic of a hazardous drug and 

published for comment in NIOSH 

docket number 105. 

After review by experts, public review 

and comment, input from stakeholders 

and review of the scientific literature, 

NIOSH has proposed a second draft list 

of hazardous drugs. A number of drugs 

were removed from the initial proposed 

list based on comments from the various 

groups and organizations. The second 

draft list identifies 24 drugs that fit the 

NIOSH definition of hazardous drugs. 

Based on comments received by NIOSH, 

Bacillus Calmette-Guerin (BCG) will be 

removed from Appendix A in the 2004 


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