[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Rules and Regulations]
[Pages 9589-9593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03001]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 1

RIN 2900-AO45


Disclosures To Participate in State Prescription Drug Monitoring 
Programs

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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SUMMARY: The Department of Veterans Affairs (VA) amends its regulations 
concerning the sharing of certain patient information in order to 
implement VA's authority to participate in State Prescription Drug 
Monitoring Programs (PDMPs). Participation in PDMPs will allow the VA 
patient population to benefit from the reduction in negative health 
outcomes.

DATES: Effective Date: This rule is effective on February 11, 2013.
    Comment Date: Comments must be received on or before April 12, 
2013.

ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulations 
Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue 
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. 
Comments should indicate that they are submitted in response to ``RIN 
2900-AO45, Disclosures to Participate in State Drug Monitoring 
Programs.'' Copies of comments received will be available for public 
inspection in the Office of Regulation Policy and Management, Room 
1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through 
Friday (except holidays). Please call (202) 461-4902 for an 
appointment. (This is not a toll-free number.) In addition, during the 
comment period, comments may be viewed online through the Federal 
Docket Management System (FDMS) at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Stephania Griffin, Director, 
Information Access and Privacy Office (10P2C1), Veterans Health 
Administration, 810 Vermont Avenue NW., Washington, DC 20420, 704-245-
2492. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On December 23, 2011, the President signed 
into law the Consolidated Appropriations Act, 2012 (the Act), Public 
Law 112-74. Section 230 of the Act amended 38 U.S.C. 5701, which 
governs the confidential nature of VA claims and information of present 
and former members of the Armed Forces and their dependents in VA's 
possession, by adding a new subsection (l), which reads as follows:

    Under regulations the Secretary [of Veterans Affairs] shall 
prescribe, the Secretary may disclose information about a veteran or 
the dependent of a veteran to a State controlled substance 
monitoring program, including a program approved by the Secretary of 
Health and Human Services under section 399O of the Public Health 
Service Act (42 U.S.C. 280g-3), to the extent necessary to prevent 
misuse and diversion of prescription medicines.

    Section 230 of the Act similarly amended 38 U.S.C. 7332, which 
governs the confidentiality of VA records relating to drug abuse, 
alcoholism or alcohol abuse, infection with the human immunodeficiency 
virus, or sickle cell anemia, by adding a subparagraph (G) to 
subsection (b)(2), which sets forth exceptions to section 7332's 
privacy protections. Subparagraph (G) authorizes VA to release this 
protected information:

    [t]o a State controlled substance monitoring program, including 
a program approved by the Secretary of Health and Human Services 
under section 399O of the Public Health Service Act (42 U.S.C. 280g-
3), to the extent necessary to prevent misuse and diversion of 
prescription medicines.

    State controlled substance monitoring programs, as named in the 
Act, are commonly referred to as State prescription drug monitoring 
programs or PDMPs. States implement and maintain the PDMP databases on 
controlled substances prescribed and filled by pharmacies within their 
borders to achieve public health and law enforcement objectives.
    Sections 5701 and 7332 are VA statutes that afford privacy 
protections to the information of veterans and their dependents, as 
well as active-duty servicemembers under section 5701, and to VA 
patients with certain medical conditions. The Act authorizes new

[[Page 9590]]

exceptions to the limitations on disclosures in sections 5701 and 7332 
that permit VA to disclose information to PDMPs on veterans and their 
dependents about prescriptions of controlled substances.
    The two statutory exceptions created in the Act do not by 
themselves authorize VA to disclose information to PDMPs. In addition 
to sections 5701 and 7332, VA's authority to disclose information to 
PDMPs is subject to the Privacy Act of 1974 (5 U.S.C. 552a) and the 
Standards for Privacy of Individually Identifiable Health Information 
(HIPAA Privacy Rule, 45 CFR Parts 160 and 164). Before releasing 
information to PDMPs, under the Privacy Act, VA must publish a Federal 
Register notice establishing a routine use for the relevant system of 
records from which the information will be disclosed. VA will publish 
the required notice separate from this rulemaking. VA's authority to 
disclose the information to PDMPs under the HIPAA Privacy Rule is 
contained in 45 CFR 164.512(b), which allows disclosures to an agency 
or authority responsible for public health matters as part of its 
official mandate. The combination of these four authorities allows VA 
to disclose information pertaining to the prescriptions for controlled 
substances to veterans and their dependents.
    VA will participate in PDMPs by both disclosing and obtaining 
information from States about VA patients. By contributing to and 
reviewing PDMP databases, VA health care providers will be able to 
identify at-risk individuals and trends that will assist in the 
prevention of the accidental or intentional misuse of prescribed 
medication by veterans and their dependents. By both disclosing 
information to and acquiring information from PDMPs, VA would improve 
the public health benefits already realized by PDMPs and obtain vital 
information that will reduce the number of emergency room visits and 
overdoses attributable to prescription drug misuse and identify 
patients at risk of negative health outcomes associated with the misuse 
of prescribed controlled substances. Episodes of care associated with 
the abuse or misuse of controlled substances can be costly and VA 
anticipates a significant aggregate benefit by providing data to States 
with PDMPs. Controlled substances, when used appropriately, have proven 
to significantly improve the overall health of patients. However, these 
substances present serious health risks when they are not used strictly 
in accordance with prescribed instructions or when used along with 
other contraindicated prescription drugs. Although patients have the 
right to control their health information, and respecting this right is 
at the heart of professional ethics and patient-centered care, 
overriding the confidentiality of certain health information can be 
ethically justified to protect the health and safety of the public. 
Sharing the necessary information to participate in PDMPs supports this 
ethical justification.
    Although the Act provides authority in 38 U.S.C. 5701 and 7332 for 
VA to disclose information to PDMPs, it requires VA to promulgate 
regulations to implement the authority only under section 5701. 
However, we are promulgating regulations to implement the authority 
under both sections 5701 and 7332 for clarity. VA implements sections 
5701 and 7332 through separate bodies of regulations dedicated to each 
statute.
    The body of regulations for section 5701 is published in part 1 
under the undesignated center heading ``Release of Information From 
Department of Veterans Affairs Claimant Records.'' We are establishing 
a new section, 38 CFR 1.515, under the heading ``Disclosure of 
information to participate in state prescription drug monitoring 
programs.'' We note that current Sec.  1.515 is titled ``To commanding 
officers of State soldiers' homes.'' This rulemaking reassigns that 
section to reserved Sec.  1.523. This new Sec.  1.515 implements the 
authority created under 38 U.S.C. 5701(l) and explains the extent to 
which VA will disclose information to PDMPs. We are adding a reference 
to new Sec.  1.515 in the regulation that implements the authority 
created under 38 U.S.C. 7332(b)(2). We are adding an authority citation 
to the end of Sec.  1.515 that reflects the statutory authorities 
relied upon in this rulemaking. These authorities are discussed 
throughout the preamble.
    The body of regulations for section 7332 is published in part 1 
under the undesignated center heading ``Release of Information from 
Department of Veterans Affairs (VA) Records Relating to Drug Abuse, 
Alcoholism or Alcohol Abuse, Infection with the Human Immunodeficiency 
Virus (HIV), or Sickle Cell Anemia.'' Under that heading, this 
rulemaking creates a new Sec.  1.483 under the undesignated center 
subheading ``Disclosures Without Patient Consent.'' The new section 
cross-references new Sec.  1.515.
    This rulemaking creates new Sec.  1.515 to implement VA's authority 
to disclose information contained in a claimant's records to PDMPs and 
details the information that will be provided to PDMPs under all 
statutory and regulatory authorities. In new Sec.  1.515(b), we define 
a ``[c]ontrolled substance'' as a substance identified by United States 
Drug Enforcement Administration (DEA) regulations (21 CFR part 1308) as 
a Schedule II, III, IV, or V controlled substance. We note that the Act 
only authorizes the specific disclosure of information pertaining to 
what is commonly understood within the medical profession to be 
controlled substances. Although some States occasionally expand their 
definition of which substances may be considered controlled substances, 
the DEA regulatory list is the most universally accepted list of such 
substances. DEA is the recognized authority for establishing the list 
of controlled substances and updates the list as necessary. VA will 
rely on DEA's expertise in choosing to use these schedules to define 
the controlled substances that we will report to PDMPs.
    We specifically exclude Schedule I substances under 21 CFR part 
1308 because these substances are not dispensed by VA due to their lack 
of medical value. Therefore, VA has no data to share regarding these 
substances.
    In paragraph (b), we define a PDMP as ``a State controlled 
substance monitoring program, including a program approved by the 
Secretary of Health and Human Services under section 399O of the Public 
Health Service Act (42 U.S.C. 280g-3).'' This definition encompasses 
all existing PDMPs and will allow for VA to share information with any 
States that develop PDMPs in the future. This definition is derived 
directly from the Act.
    In paragraph (c), we state that VA may disclose to PDMPs 
information that falls under specified categories of information.
    Paragraphs (c)(1) through (3) describe the three categories of 
information that will be disclosed to PDMPs under the regulation and 
provide examples of these categories of information. The Act does not 
require, nor can VA at this time provide, a definitive list of the 
individual data elements within each category that will be shared with 
PDMPs by VA due to variances in the requirements of PDMPs. Based on 
VA's review of PDMP requirements, we believe that the information VA 
must provide to participate with the PDMPs will fall into one of these 
general categories of information, and the examples provided represent 
the specific information that will be shared with the majority of 
PDMPs.
    The examples provided under paragraphs (c)(1) through (c)(3) are 
derived from section 399O of the Public

[[Page 9591]]

Health Service Act (42 U.S.C. 280g-3). Under section 280g-3, the U.S. 
Department of Health and Human Services (HHS) authorizes grants to 
States that operate PDMPs according to the requirements set forth in 
the statute. Although the grant program is voluntary and the statute 
allows States some flexibility to require reporting of information not 
in the statute, VA will use these examples as a baseline for reporting 
data to PDMPs. This list of reporting elements was created by Congress 
when it established the HHS grant program. We believe this indicates 
that Congress finds these elements to be the most effective in meeting 
the public health goals of PDMPs. However, as stated, the elements 
within each category of information in Sec.  1.515(c) are examples. To 
better collaborate with States, VA requires flexibility to identify 
additional reporting requirements and to determine whether VA is 
capable of providing such information. VA may provide an element of 
information that falls within one of the categories even if it is not 
named as an example; however, without further rulemaking, VA will not 
provide information to PDMPs that does not fall within one of the three 
listed categories of information.
    Paragraph (c)(1) authorizes the disclosure of demographic 
information ``of veterans and dependents of veterans who are prescribed 
a controlled substance.'' The Act amends 38 U.S.C. 5701 and 7332, which 
only apply to certain patient, veteran, or veteran dependent 
information maintained by VA. VA will also disclose any additional 
information necessary to meaningfully participate in PDMPs, to the 
extent that such disclosures are authorized under the Privacy Act of 
1974 and HIPAA Privacy Rule requirements, as well as the amendments to 
sections 5701 and 7332.
    Paragraph (c)(2) authorizes sharing information about the 
prescribed controlled substance, including the substance's national 
drug code number, quantity dispensed, number of refills ordered, 
whether the prescription was a refill or for first-time use, and the 
date of origin of the prescription. Such information is critical to the 
proper use of PDMP databases to prevent misuse and protect the health 
of patients. Merely reporting a prescription of a particular substance 
will not provide the context necessary to determine if the prescription 
is appropriate in relation to the patient's condition and other 
prescriptions.
    Paragraph (c)(3) explains that certain prescriber information will 
be shared with PDMPs. Such information identifies where an individual 
is receiving care and the identity of the provider, which may 
facilitate communication between providers when necessary to prevent 
negative health outcomes. Such information is also required by PDMPs in 
order to regulate the quality of contributions to their databases and 
prevent fraudulent or erroneous reporting.
    As a technical matter, we note that one section previously reserved 
by VA in the CFR is no longer reserved. Title 38 of the CFR currently 
contains a specific reservation for Sec. Sec.  1.480 through 1.483. 
This rulemaking creates new Sec.  1.483 and intends for this section to 
be published under the undesignated center subheading ``Disclosures 
Without Patient Consent.'' The CFR should be updated to correctly 
reserve Sec. Sec.  1.480 through 1.482.

Effect of Rulemaking

    Title 38 of the CFR, as revised by this interim final rulemaking, 
represents VA's implementation of its legal authority on this subject. 
Other than future amendments to this regulation or governing statutes, 
no contrary guidance or procedures on this subject are authorized. All 
VA guidance must be read to conform with this rulemaking if possible 
or, if not possible, such guidance is superseded by this rulemaking.

Administrative Procedure Act

    In accordance with 5 U.S.C. 553(b)(B), the Secretary of Veterans 
Affairs finds good cause to issue this interim final rule without prior 
notice and comment. This interim final rule implements VA's authorized 
participation in State PDMPs to identify and prevent potential misuse 
of prescription drugs and assist in avoiding negative health outcomes 
for VA patients, including emergency treatment and accidental overdose. 
As increasing numbers of veterans return from active duty with complex, 
catastrophic injuries for which pain must be controlled in part by the 
use of controlled substance medications, VA clinicians require the most 
complete patient information available. The misuse of prescription 
medication has reached epidemic levels nationwide, and the veteran 
population is at a heightened risk for negative health outcomes 
associated with the improper use of controlled substances. Veterans are 
subject to unique risk factors involving the misuse of prescribed 
controlled substances. Karen H. Seal et al., ``Association of Mental 
Health Disorders With Prescription Opioids and High-Risk Opioid Use in 
US Veterans of Iraq and Afghanistan,'' 307 JAMA 940 (2012). The 
conflicts in Iraq and Afghanistan have led to a sharp increase in the 
number of servicemembers and veterans returning with serious injuries 
that present symptoms associated with severe pain. Recent studies 
indicate that almost half of veterans who served in Operation Enduring 
Freedom and/or Operation Iraqi Freedom, and entered VA health care from 
2005 through 2008 received at least one pain-related diagnosis, and of 
those who received such diagnosis, 66 percent received more than one 
pain diagnosis. Other risk factors present in the veteran population 
such as increased rates of homelessness, suicide attempts, and alcohol 
and other substance-abuse disorders increase the likelihood that an 
individual will misuse prescribed controlled substances and suffer 
negative health outcomes. Karen H. Seal et al., ``Association of Mental 
Health Disorders With Prescription Opioids and High-Risk Opioid Use in 
US Veterans of Iraq and Afghanistan,'' 307 JAMA 940 (2012).
    In addition to promoting the health and safety of VA's patient 
population, there are exigent public health reasons not to delay 
implementation of this rule. The abuse of prescription drugs is growing 
rapidly throughout the United States. Controlled substances prescribed 
for pain are misused by patients and often result in negative health 
outcomes including emergency hospital visitations and overdose. The 
U.S. Department of Health and Human Services estimates that in 2009 
more than 1 million emergency department visits nationwide involved the 
non-medical use of pharmaceuticals, more than doubling in number 
compared to 2004. Substance Abuse & Mental Health Servs. Admin., U.S. 
Dep't of Health & Human Servs., Drug Abuse Warning Network, 2009: Nat'l 
Estimates of Drug-Related Emergency Dep't Visits (2011). In 2009 alone, 
more than 37,000 Americans died from drug overdoses, with 15,500 deaths 
being attributable to opioids. Ctrs. for Disease Control & Prevention, 
U.S. Dep't of Health & Human Servs., Underlying Cause of Death 1999-
2009, CDC WONDER Database (2012). Pain-relief medications, including 
controlled substances, are the most frequent form of medication used in 
suicide attempts via overdose.
    State PDMPs are effective in detecting and preventing prescription 
medication misuse. One of the primary risk factors for individuals who 
overdose on opioids, controlled substances generally prescribed for 
pain, is ``doctor shopping,'' or obtaining multiple prescriptions from 
different providers.

[[Page 9592]]

Alan G. White et al., ``Analytic Models to Identify Patients at Risk 
for Prescription Opioid Abuse,'' 15 Am J. Managed Care 897 (2009). 
PDMPs in States with robust monitoring programs have shown some success 
in curbing the rapid growth in opioid consumption occurring nationally. 
Leonard J. Paulozzi & Daniel D. Stier, ``Prescription drug laws, drug 
overdoses, and drug sales in New York and Pennsylvania,'' 31 J. of Pub. 
Health Pol'y 422 (2010). Although many PDMPs are relatively new and 
data is limited, preliminary data indicates that PDMPs are associated 
with mitigated risks of abuse and misuse of opioids in the general 
population over time. Liza M. Reifler et al., ``Do Prescription 
Monitoring Programs Impact State Trends in Opioid Abuse/Misuse?'' 13 
Pain Med. 434 (2012). Some states have also noted that reporting 
individuals to the PDMP has reduced the number of doctors and 
pharmacies visited. ``Nevada's Proactive PMP: The Impact of Unsolicited 
Reports,'' Prescription Monitoring Program Ctr. of Excellence, Brandeis 
Univ. (Oct. 2011), http://www.pmpexcellence.org/sites/all/pdfs/nevada_nff_10_26_11.pdf. In 2002, Congress recognized their value by 
beginning to provide funding to support these programs and has 
continued to do so since. Effective PDMPs have also coincided with 
reductions in the rate of hospital admissions related to the misuse of 
controlled substances. Leonard J. Paulozzi & Daniel D. Stier, 
``Prescription drug laws, drug overdoses, and drug sales in New York 
and Pennsylvania,'' 31 J. of Pub. Health Pol'y 422 (2010).
    For these reasons, the Secretary has concluded that ordinary notice 
and comment procedures would be impracticable and contrary to the 
public interest and is accordingly issuing this rule as an interim 
final rule. In order to ensure timely implementation of the program 
established by this rule, and for the reasons stated above, the 
Secretary also finds, in accordance with 5 U.S.C. 553(d)(3), that there 
is good cause for this interim final rule to be effective immediately 
upon publication. For the same reasons detailed above, it is in the 
public's interest to commence this program as soon as possible, and 
this will be facilitated by an immediate effective date.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any given year. This interim final rule will have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Paperwork Reduction Act

    This interim final rule contains no provisions constituting a 
collection of information under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this regulatory action will not 
have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act, 5 
U.S.C. 601-12. This regulatory action affects only individuals and will 
not affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), 
this regulatory action is exempt from the initial and final flexibility 
analysis requirements of sections 603 and 604.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' which requires review by the Office 
of Management and Budget (OMB), as ``any regulatory action that is 
likely to result in a rule that may: (1) Have an annual effect on the 
economy of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local, or tribal 
governments or communities; (2) Create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) Materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined to be a significant regulatory action under Executive 
Order 12866.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
this rule are 64.012 Veterans Prescription Service and 64.019 Veterans 
Rehabilitation-Alcohol and Drug Dependence.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. John R. 
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this 
document on February 5, 2013, for publication.

List of Subjects in 38 CFR Part 1

    Administrative practice and procedure, Archives and records, 
Cemeteries, Claims, Courts, Crime, Flags, Freedom of Information, 
Government employees, Government property, Infants and children, 
Inventions and patents, Parking, Penalties, Privacy, Reporting and 
recordkeeping requirements, Seals and insignia, Security measures, 
Wages.

    Dated: February 6, 2013.
Robert C. McFetridge,
Director of Regulation Policy and Management, Office of the General 
Counsel, Department of Veterans Affairs.
    For the reasons set out in the preamble, VA amends 38 CFR part 1 as 
follows:

PART 1--GENERAL PROVISIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  38 U.S.C. 501(a), and as noted in specific sections.


0
2. Section 1.483 is added immediately following the undesignated center 
heading ``Disclosures Without Patient Consent'' to read as follows:


Sec.  1.483  Disclosure of information to participate in state 
prescription drug monitoring programs.

    Information covered by Sec. Sec.  1.460 through 1.499 of this part 
may be disclosed to State Prescription Drug Monitoring Programs 
pursuant to the

[[Page 9593]]

limitations set forth in Sec.  1.515 of this part.

0
3. Section 1.515 is redesignated as Sec.  1.523 and a new Sec.  1.515 
is added to read as follows:


Sec.  1.515  Disclosure of information to participate in state 
prescription drug monitoring programs.

    (a) General. Information covered by Sec. Sec.  1.500 through 1.527 
of this part may be disclosed to State Prescription Drug Monitoring 
Programs pursuant to the limitations set forth in paragraph (c) of this 
section.
    (b) Definitions. For the purposes of this section:
    Controlled substance means any substance identified in 21 CFR part 
1308 as a schedule II, III, IV, or V controlled substance.
    State Prescription Drug Monitoring Program (PDMP) means a State 
controlled substance monitoring program, including a program approved 
by the Secretary of Health and Human Services under section 399O of the 
Public Health Service Act (42 U.S.C. 280g-3).
    (c) Participation in PDMPs. VA may disclose to PDMPs any of the 
following information concerning the prescription of controlled 
substances:
    (1) Demographic information of veterans and dependents of veterans 
who are prescribed a controlled substance. Examples include name, 
address, and telephone number.
    (2) Information about the prescribed controlled substances. 
Examples include the identification of the substance by a national drug 
code number, quantity dispensed, number of refills ordered, whether the 
substances were dispensed as a refill of a prescription or as a first-
time request, and date of origin of the prescription.
    (3) Prescriber information. Examples include the prescriber's 
United States Drug Enforcement Administration-issued identification 
number authorizing the individual to prescribe controlled substances 
and United States Department of Health and Human Services-issued 
National Provider Identifier number.

(Authority: 5 U.S.C. 552a; 38 U.S.C. 5701, 7332; 45 CFR 164.512(b))


[FR Doc. 2013-03001 Filed 2-8-13; 8:45 am]
BILLING CODE 8320-01-P