Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process, 18364-18365 [2013-06918]

Download as PDF 18364 Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices reappointment of Daniel J. Little may submit written comments to the address listed above. Comments must be received by April 25, 2013. Dated: March 20, 2013. Ken Salazar, Secretary. [FR Doc. 2013–06853 Filed 3–25–13; 8:45 am] BILLING CODE 4310–10–P DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140–0004] Agency Information Collection Activities; Proposed Collection; Comments Requested: Interstate Firearms Shipment Report of Theft/Loss srobinson on DSK4SPTVN1PROD with NOTICES ACTION: 60-Day notice. The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for ‘‘sixty days’’ until [insert the date 60 days from the date this notice is published in the Federal Register]. This process is conducted in accordance with 5 CFR 1320.10. If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Ben Hayes, Benjamin.Hayes@atf.gov, ATF National Tracing Center, 244 Needy Road, Martinsburg, WV 25405. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, VerDate Mar<15>2010 19:07 Mar 25, 2013 Jkt 229001 including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Summary of Information Collection (1) Type of Information Collection: Extension of a currently approved collection. (2) Title of the Form/Collection: Interstate Firearms Shipment Report of Theft/Loss. (3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: ATF F 3310.6. Bureau of Alcohol, Tobacco, Firearms and Explosives. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other forprofit. Other: None. Need for Collection The form is part of a voluntary program in which the common carrier and/or shipper report losses or thefts of firearms from interstate shipments. ATF uses this information to ensure that the firearms are entered into the National Crime Information Center to initiate investigations and to perfect criminal cases. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 550 respondents will complete a 20 minute form. (6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 182 annual total burden hours associated with this collection. If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, 145 N Street NE., Room 3W–1407B, Washington, DC 20530. Dated: March 20, 2013. Jerri Murray, Department Clearance Officer, PRA, U.S. Department of Justice. [FR Doc. 2013–06779 Filed 3–25–13; 8:45 am] BILLING CODE 4810–FY–P PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–364] Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice. AGENCY: SUMMARY: DEA is announcing two new DEA-approved certification processes for providers of Electronic Prescriptions for Controlled Substances (EPCS) applications. Certifying organizations with a certification process approved by DEA pursuant to 21 Code of Federal Regulations (CFR) 1311.300(e) are posted on DEA’s Web site upon approval. FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 307–7165. SUPPLEMENTARY INFORMATION: Background The Drug Enforcement Administration (DEA) implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Import and Export Act (21 U.S.C. 801–971), as amended, and referred to as the Controlled Substances Act (CSA).1 DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes. The CSA and DEA’s implementing regulations establish the legal requirements for possessing and dispensing controlled substances, including the issuance of a prescription for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. ‘‘The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but 1 The Attorney General’s delegation of authority to DEA may be found at 28 CFR 0.100. E:\FR\FM\26MRN1.SGM 26MRN1 Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices a corresponding responsibility rests with the pharmacist who fills the prescription.’’ 21 CFR 1306.04(a). A prescription serves both as a record of the practitioner’s determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing. The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been properly dispensed. The maintenance of complete and accurate prescription records is an essential part of the overall CSA regulatory scheme established by Congress. Electronic Prescriptions for Controlled Substances (EPCS) Historically, where federal law required that a prescription for a controlled substance be issued in writing, that requirement could only be satisfied through the issuance of a paper prescription. Given advancements in technology and security capabilities for electronic applications, DEA amended its regulations to provide practitioners with the option of issuing electronic prescriptions for controlled substances in lieu of paper prescriptions. Efforts to develop EPCS capabilities have been underway for a number of years. DEA’s Interim Final Rule for Electronic Prescriptions for Controlled Substances was published on March 31, 2010, at 75 FR 16236–16319, and became effective on June 1, 2010. srobinson on DSK4SPTVN1PROD with NOTICES Update Certifying Organizations With a Certification Process Approved by DEA Pursuant to 21 CFR 1311.300(e) As noted above, the Interim Final Rule provides that, as an alternative to the audit requirements of 21 CFR 1311.300(a) through (d), an electronic prescription or pharmacy application may be verified and certified as meeting the requirements of 21 CFR Part 1311 by a certifying organization whose certification process has been approved by DEA. The preamble to the Interim Final Rule further indicated that, once a qualified certifying organization’s certification process has been approved by DEA in accordance with 21 CFR 1311.300(e), such information will be posted on DEA’s Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the certification processes developed by Global Sage Group, LLC, and by iBeta, LLC. iBeta’s certification process was previously approved by DEA but only with regard VerDate Mar<15>2010 19:07 Mar 25, 2013 Jkt 229001 to the certification of the application’s biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for iBeta’s certification process is expanded to include the entire certification process. Relevant information has been posted on DEA’s Web site at http:// www.DEAdiversion.usdoj.gov. Dated: March 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 2013–06918 Filed 3–25–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission Commencement of Iraq Claims Adjudication Program Foreign Claims Settlement Commission of the United States. ACTION: Notice. AGENCY: SUMMARY: This notice announces the commencement by the Foreign Claims Settlement Commission (‘‘Commission’’) of a program for adjudication of a certain category of claims of United States nationals against the Government of Iraq, as defined below, which were settled under the ‘‘Claims Settlement Agreement Between the Government of the United States of America and the Government of the Republic of Iraq,’’ dated September 2, 2010 (‘‘Claims Settlement Agreement’’). DATES: These claims can now be filed with the Commission and the deadline for filing will be June 26, 2013. The deadline for completion of this claims adjudication program will be March 26, 2014. FOR FURTHER INFORMATION CONTACT: Brian M. Simkin, Chief Counsel, Foreign Claims Settlement Commission, 600 E Street NW., Room 6002, Washington, DC 20579, Tel. (202) 616–6975, FAX (202) 616–6993. Notice of Commencement of Claims Adjudication Program, and of Program Completion Date Pursuant to the authority conferred upon the Secretary of State and the Commission under section 4(a)(1)(C) of Title I of the International Claims Settlement Act of 1949, as amended (22 U.S.C. 1623(a)(1)(C)), the Foreign Claims Settlement Commission hereby gives notice of the commencement of a program for adjudication of a category of claims of United States nationals against the Government of Iraq. These claims, PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 18365 which have been referred to the Commission by the Department of State by letter dated November 14, 2012, are defined as: claims of U.S. nationals for compensation for serious personal injuries knowingly inflicted upon them by Iraq 1 in addition to amounts already recovered under the Claims Settlement Agreement for claims of hostagetaking 2 provided that (1) the claimant has already received compensation under the Claims Settlement Agreement from the Department of State 3 for his or her claim of hostage-taking, and such compensation did not include economic loss based on a judgment against Iraq, and (2) the Commission determines that the severity of the serious personal injury suffered is a special circumstance warranting additional compensation. For purposes of this referral, ‘‘serious personal injury’’ may include instances of serious physical, mental, or emotional injury arising from sexual assault, coercive interrogation, mock execution, or aggravated physical assault. In conformity with the terms of the referral, the Commission will determine the claims in accordance with the provisions of Title I of the International Claims Settlement Act of 1949, as amended, 22 U.S.C. 1621 et seq. The Commission will then certify to the Secretary of the Treasury those claims that it finds to be valid, for payment out of the claims fund established under the Claims Settlement Agreement. The Commission will administer this claims adjudication program in accordance with its regulations, which are published in Chapter V of Title 45, Code of Federal Regulations (45 CFR 500 et seq.). In particular, attention is directed to 45 CFR 500.3(a), which limits the amount of attorney’s fees that may be charged for legal representation before the Commission pursuant to 22 U.S.C. 1623(f). These regulations are also available at http:// www.gpoaccess.gov/cfr/index.html. Approval has been obtained from the Office of Management and Budget for the collection of this information. 1 For purposes of this referral, ‘‘Iraq’’ shall mean the Republic of Iraq, the Government of the Republic of Iraq, any agency or instrumentality of the Republic of Iraq, and any official, employee or agent of the Republic of Iraq acting within the scope of his or her office, employment or agency. 2 Hostage-taking, in this instance, would include unlawful detention by Iraq that resulted in an inability to leave Iraq or Kuwait after Iraq invaded Kuwait on August 2, 1990. 3 The payment already received by the claimant under the Claims Settlement Agreement compensated the claimant for his or her experience for the entire duration of the period in which the claimant was held hostage or was subject to unlawful detention and encompassed physical, mental, and emotional injuries generally associated with such captivity or detention. E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18364-18365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06918]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-364]


Electronic Prescriptions for Controlled Substances Notice of 
Approved Certification Process

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice.

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SUMMARY: DEA is announcing two new DEA-approved certification processes 
for providers of Electronic Prescriptions for Controlled Substances 
(EPCS) applications. Certifying organizations with a certification 
process approved by DEA pursuant to 21 Code of Federal Regulations 
(CFR) 1311.300(e) are posted on DEA's Web site upon approval.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:

Background

    The Drug Enforcement Administration (DEA) implements and enforces 
Titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970 and the Controlled Substances Import and Export Act 
(21 U.S.C. 801-971), as amended, and referred to as the Controlled 
Substances Act (CSA).\1\ DEA publishes the implementing regulations for 
these statutes in Title 21 of the Code of Federal Regulations (CFR), 
Parts 1300 to 1321. The CSA and its implementing regulations are 
designed to prevent, detect, and eliminate the diversion of controlled 
substances and listed chemicals into the illicit market while ensuring 
a sufficient supply of controlled substances and listed chemicals for 
legitimate medical, scientific, research, and industrial purposes.
---------------------------------------------------------------------------

    \1\ The Attorney General's delegation of authority to DEA may be 
found at 28 CFR 0.100.
---------------------------------------------------------------------------

    The CSA and DEA's implementing regulations establish the legal 
requirements for possessing and dispensing controlled substances, 
including the issuance of a prescription for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice. ``The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but

[[Page 18365]]

a corresponding responsibility rests with the pharmacist who fills the 
prescription.'' 21 CFR 1306.04(a). A prescription serves both as a 
record of the practitioner's determination of the legitimate medical 
need for the drug to be dispensed, and as a record of the dispensing. 
The prescription also provides a record of the actual dispensing of the 
controlled substance to the ultimate user (the patient) and, therefore, 
is critical to documenting that controlled substances held by a 
pharmacy have been properly dispensed. The maintenance of complete and 
accurate prescription records is an essential part of the overall CSA 
regulatory scheme established by Congress.

Electronic Prescriptions for Controlled Substances (EPCS)

    Historically, where federal law required that a prescription for a 
controlled substance be issued in writing, that requirement could only 
be satisfied through the issuance of a paper prescription. Given 
advancements in technology and security capabilities for electronic 
applications, DEA amended its regulations to provide practitioners with 
the option of issuing electronic prescriptions for controlled 
substances in lieu of paper prescriptions. Efforts to develop EPCS 
capabilities have been underway for a number of years. DEA's Interim 
Final Rule for Electronic Prescriptions for Controlled Substances was 
published on March 31, 2010, at 75 FR 16236-16319, and became effective 
on June 1, 2010.

Update

Certifying Organizations With a Certification Process Approved by DEA 
Pursuant to 21 CFR 1311.300(e)

    As noted above, the Interim Final Rule provides that, as an 
alternative to the audit requirements of 21 CFR 1311.300(a) through 
(d), an electronic prescription or pharmacy application may be verified 
and certified as meeting the requirements of 21 CFR Part 1311 by a 
certifying organization whose certification process has been approved 
by DEA. The preamble to the Interim Final Rule further indicated that, 
once a qualified certifying organization's certification process has 
been approved by DEA in accordance with 21 CFR 1311.300(e), such 
information will be posted on DEA's Web site. 75 FR 16243 (March 31, 
2010). On January 18, 2013, DEA approved the certification processes 
developed by Global Sage Group, LLC, and by iBeta, LLC. iBeta's 
certification process was previously approved by DEA but only with 
regard to the certification of the application's biometrics subsystem, 
including its interfaces. 77 FR 45688 (August 1, 2012). This approval 
for iBeta's certification process is expanded to include the entire 
certification process. Relevant information has been posted on DEA's 
Web site at http://www.DEAdiversion.usdoj.gov.

    Dated: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2013-06918 Filed 3-25-13; 8:45 am]
BILLING CODE 4410-09-P