81_FR_40841 81 FR 40721 - Proposed Collection of Information; Comment Request

81 FR 40721 - Proposed Collection of Information; Comment Request

DEPARTMENT OF LABOR
Office of Workers' Compensation Programs

Federal Register Volume 81, Issue 120 (June 22, 2016)

Page Range40721-40722
FR Document2016-14818

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506 (c)(2)(A)] This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Authorization Request form and Certification/Letter of Medical Necessity for Compounded Drugs (CA-26) and Authorization Request form and Certification/Letter of Medical Necessity for Opioid Medications (CA- 27). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

Federal Register, Volume 81 Issue 120 (Wednesday, June 22, 2016) 
[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40721-40722]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14818]


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DEPARTMENT OF LABOR

Office of Workers' Compensation Programs


Proposed Collection of Information; Comment Request

AGENCY: Division of Federal Employees' Compensation, Office of Workers' 
Compensation Programs, Department of Labor.

ACTION: Notice.

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SUMMARY: The Department of Labor, as part of its continuing effort to 
reduce paperwork and respondent burden, conducts a preclearance 
consultation program to provide the general public and Federal agencies 
with an opportunity to comment on proposed and/or continuing 
collections of information in accordance with the paperwork Reduction 
Act of 1995 (PRA95) [44 U.S.C. 3506 (c)(2)(A)] This program helps to 
ensure that requested data can be provided in the desired format, 
reporting burden (time and financial resources) is minimized, 
collection instruments are clearly understood, and the impact of 
collection requirements on respondents can be properly assessed.

[[Page 40722]]

    Currently, the Office of Workers' Compensation Programs is 
soliciting comments concerning the proposed collection: Authorization 
Request form and Certification/Letter of Medical Necessity for 
Compounded Drugs (CA-26) and Authorization Request form and 
Certification/Letter of Medical Necessity for Opioid Medications (CA-
27). A copy of the proposed information collection request can be 
obtained by contacting the office listed below in the addresses section 
of this Notice.

DATES: Written comments must be submitted to the office listed in the 
addresses section below on or before August 22, 2016.

ADDRESSES: Ms. Yoon Ferguson, U.S. Department of Labor, 200 
Constitution Ave. NW., Room S-3323, Washington, DC 20210, telephone/fax 
(202) 354-9647, Email [email protected]. Please use only one method 
of transmission for comments (mail or Email).

SUPPLEMENTARY INFORMATION: 

I. Background

    The Department of Labor (DOL) is requesting an approval of a new 
information collection. This information collection is essential to the 
mission of DOL and the Office of Workers' Compensation Programs (OWCP), 
to monitor and assure the appropriate use of opioids and compounded 
drugs in treating employment-related injuries under the Federal 
Employees Compensation Act (FECA), 5 U.S.C. 8101 et seq.
    The FECA statute grants OWCP discretion to provide an injured 
employee the ``services, appliances, and supplies prescribed or 
recommended by a qualified physician'' which OWCP considers ``likely to 
cure, give relief, reduce the degree or the period of disability, or 
aid in lessening the amount of the monthly compensation.'' 5 U.S.C. 
8103. In other words, OWCP is mandated to provide medical supplies and 
services--including prescription drugs such as opioids and compounded 
drugs--that it considers medically necessary. 20 CFR 10.310. The FECA 
statute and implementing regulations are not primarily focused on 
managing doctor/patient decisions relating to medication therapy and, 
with the exception of few limitations on fentanyl (an opioid) and other 
controlled substances, the FECA program policy on pharmacy benefits has 
generally been a policy of payment for prescribed medications in 
accordance with a fee schedule based on a percentage of the average 
wholesale price (AWP) for drugs identified by a National Drug Code 
(NDC). See 20 CFR 10.809. The FECA program does not currently have any 
limitations on payment for opioids generally or for compounded drugs. 
The FECA program is establishing a prior authorization policy for 
opioid and compounded drugs (at this time after first fill) utilizing 
the pre-authorization authority already contained in its regulations at 
20 CFR 10.310(a) and Sec.  10.800(b). In requiring the use of these 
forms for opioid and compounded drugs, OWCP is implementing a prior-
authorization process based on medical necessity.
    The forms, Authorization Request Form and Certification/Letter of 
Medical Necessity for Compounded Drugs (CA-26) and Authorization 
Request Form and Certification/Letter of Medical Necessity 
Certification/Letter of Medical Necessity for Opioid Medications (CA-
27), require an injured worker's treating physician to answer a number 
of questions about the prescribed opioids and/or compounded drugs and 
certify that they are medically necessary to treat the work-related 
injury. The responses to the questions on the forms are intended to 
ensure that treating physicians have considered non-opioid and non-
compounded drug alternatives, and are only prescribing the most cost 
effective and medically necessary drugs. The forms will also permit 
OWCP to more easily track the volume, type, and characteristics of 
opioids and compounded drugs authorized by the FECA program. The forms 
will serve as a means for injured workers to continue receiving opioids 
and compounded drugs only where medically necessary and simultaneously 
give OWCP greater oversight in monitoring their appropriate use and 
gather additional data about their use.

II. Review Focus

    The Department of Labor is particularly interested in comments 
which:
     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, 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 submissions of responses.

III. Current Actions

    The Department of Labor seeks the approval of this new information 
collection in order to carry out its responsibility to meet the 
statutory requirements of the Federal Employees' Compensation Act.
    Agency: Office of Workers' Compensation Programs.
    Type of Review: New Collection (Request for New OMB control 
Number).
    Title: Authorization and Certification/Letter of Medical Necessity.
    OMB Number: 1240-0NEW.
    Agency Number: CA-26 and CA-27.
    Affected Public: Individuals or households; Businesses or other 
for-profit.
    Total Respondents: 80,000.
    Total Annual Responses: 65,600.
    Estimated Total Burden Hours: 40,000.
    Estimated Time per Response: 30 minutes.
    Frequency: On occasion.
    Total Burden Cost (capital/startup): $0.
    Total Burden Cost (operating/maintenance): $0.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
approval of the information collection request; they will also become a 
matter of public record.

    Dated: June 16, 2016.
Yoon Ferguson,
Agency Clearance Officer, Office of Workers' Compensation Programs, 
U.S. Department of Labor.
[FR Doc. 2016-14818 Filed 6-21-16; 8:45 am]
 BILLING CODE 4510-CH-P

Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices 40721 receiving mail in the Washington, DC proposed new information collection for the proper performance of the area, commenters are strongly activity for the TAACCCT Round 4 functions of the agency, including encouraged to transmit their comments National Evaluation: (1) Collecting whether the information will have electronically via email or to submit updated participant contact practical utility; them by mail early. Comments, information, (2) conducting a follow-up * evaluate the accuracy of the including any personal information survey of participants enrolled in agency’s estimate of the burden of the provided, become a matter of public programs in the Round 4 grantees proposed collection of information, record. They will also be summarized selected for the outcomes study, (3) including the validity of the and/or included in the request for OMB surveying staff in all colleges that are methodology and assumptions used; approval of the information collection part of a Round 4 grant, and (4) * enhance the quality, utility, and request. interviewing staff from employers that clarity of the information to be FOR FURTHER INFORMATION CONTACT: have partnered with Round 4 grantees. collected; and Molly Irwin and Janet Javar by email at The purposes of the outcomes study * minimize the burden of the ChiefEvaluationOffice@dol.gov. are to capture participants’ training information collection on those who are SUPPLEMENTARY INFORMATION: experiences while in their programs, to respond, including the use of I. Background: The fourth round of receipt of job search assistance as they appropriate automated, electronic, the Trade Adjustment Assistance near program completion, and mechanical, or other technological Community College Career Training employment and wage outcomes upon collection techniques or other forms of (TAACCCT) grants program continues to program exit and, for shorter programs, information technology, e.g., permitting provide community colleges and other several months thereafter. The employer electronic submissions of responses. eligible institutions of higher education study will seek to understand how DOL III. Current Actions: At this time, the with funds to expand and improve their can encourage the workforce system to Department of Labor is requesting ability to deliver education and career build productive and sustainable clearance for data collection for the training programs that can be completed employer relationships through national evaluation of Round 4 of the in two years or less and are suited for Workforce Innovation and Opportunity TAACCCT grants program via collection workers who are eligible for training Act implementation and its grants of updated participant contact under the Trade Adjustment Assistance programs. information, survey data on participants for Workers program and other adults in II. Desired Focus of Comments: and colleges, and employer discussions. need of new or upgraded skills. The Currently, the Department of Labor is Type of review: New information evaluation of Round 4 funded by the soliciting comments concerning the collection request. Department of Labor will include an above data collection for the national OMB Control Number: 1205–0NEW. outcomes study, an implementation evaluation of Round 4 of the TAACCCT Affected Public: Participants enrolled analysis, and a study of employer grants program. Comments are in selected TAACCCT grant programs; relationships. requested to: staff associated with implementing This Federal Register Notice provides * Evaluate whether the proposed TAACCCT grant programs, employers the opportunity to comment on a collection of information is necessary working with TAACCCT grantees. ESTIMATED BURDEN HOURS Total number Annual Number of Average time Total burden Annual burden Form/activity of number of responses per per response hours hours respondents respondents respondent (hours) Participant Follow-up Survey ................... * 4,000 1,333 1 .33 1,320 440 Updates to Participant Contact informa- tion ........................................................ 5,000 1,667 4 0.083 1,660 553 College Survey ......................................... 272 91 1 1.5 408 137 Employer Interviews ................................. 136 45 1 1.5 204 68 Totals ................................................ 9,408 4,704 ........................ ........................ 3,592 1,197 * Assumes a sample of 5,000 with an 80 percent response rate. Comments submitted in response to DEPARTMENT OF LABOR conducts a preclearance consultation this request will be summarized and/or program to provide the general public included in the request for Office of Office of Workers’ Compensation and Federal agencies with an Management and Budget approval; they Programs opportunity to comment on proposed will also become a matter of public and/or continuing collections of Proposed Collection of Information; information in accordance with the record. Comment Request Signed at Washington, DC, this 6th day of paperwork Reduction Act of 1995 June 2016. AGENCY: Division of Federal Employees’ (PRA95) [44 U.S.C. 3506 (c)(2)(A)] This Compensation, Office of Workers’ program helps to ensure that requested mstockstill on DSK3G9T082PROD with NOTICES Sharon Block, Compensation Programs, Department of data can be provided in the desired Principal Deputy Assistant Secretary for format, reporting burden (time and Labor. Policy, U.S. Department of Labor. ACTION: Notice. financial resources) is minimized, [FR Doc. 2016–14819 Filed 6–21–16; 8:45 am] collection instruments are clearly BILLING CODE 4510–HX–P SUMMARY: The Department of Labor, as understood, and the impact of collection part of its continuing effort to reduce requirements on respondents can be paperwork and respondent burden, properly assessed. VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1

40722 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Notices Currently, the Office of Workers’ (NDC). See 20 CFR 10.809. The FECA electronic, mechanical, or other Compensation Programs is soliciting program does not currently have any technological collection techniques or comments concerning the proposed limitations on payment for opioids other forms of information technology, collection: Authorization Request form generally or for compounded drugs. The e.g., permitting electronic submissions and Certification/Letter of Medical FECA program is establishing a prior of responses. Necessity for Compounded Drugs (CA– authorization policy for opioid and 26) and Authorization Request form and compounded drugs (at this time after III. Current Actions Certification/Letter of Medical Necessity first fill) utilizing the pre-authorization The Department of Labor seeks the for Opioid Medications (CA–27). A copy authority already contained in its approval of this new information of the proposed information collection regulations at 20 CFR 10.310(a) and collection in order to carry out its request can be obtained by contacting § 10.800(b). In requiring the use of these responsibility to meet the statutory the office listed below in the addresses forms for opioid and compounded requirements of the Federal Employees’ section of this Notice. drugs, OWCP is implementing a prior- Compensation Act. DATES: Written comments must be authorization process based on medical Agency: Office of Workers’ submitted to the office listed in the necessity. Compensation Programs. addresses section below on or before The forms, Authorization Request Type of Review: New Collection August 22, 2016. Form and Certification/Letter of Medical (Request for New OMB control ADDRESSES: Ms. Yoon Ferguson, U.S. Necessity for Compounded Drugs (CA– Number). Department of Labor, 200 Constitution 26) and Authorization Request Form Title: Authorization and Certification/ Ave. NW., Room S–3323, Washington, and Certification/Letter of Medical Letter of Medical Necessity. DC 20210, telephone/fax (202) 354– Necessity Certification/Letter of Medical OMB Number: 1240–0NEW. 9647, Email ferguson.yoon@dol.gov. Necessity for Opioid Medications (CA– Agency Number: CA–26 and CA–27. 27), require an injured worker’s treating Affected Public: Individuals or Please use only one method of physician to answer a number of households; Businesses or other for- transmission for comments (mail or questions about the prescribed opioids profit. Email). and/or compounded drugs and certify Total Respondents: 80,000. SUPPLEMENTARY INFORMATION: that they are medically necessary to Total Annual Responses: 65,600. I. Background treat the work-related injury. The Estimated Total Burden Hours: responses to the questions on the forms 40,000. The Department of Labor (DOL) is are intended to ensure that treating Estimated Time per Response: 30 requesting an approval of a new physicians have considered non-opioid minutes. information collection. This information and non-compounded drug alternatives, Frequency: On occasion. collection is essential to the mission of and are only prescribing the most cost Total Burden Cost (capital/startup): DOL and the Office of Workers’ effective and medically necessary drugs. $0. Compensation Programs (OWCP), to The forms will also permit OWCP to Total Burden Cost (operating/ monitor and assure the appropriate use more easily track the volume, type, and maintenance): $0. of opioids and compounded drugs in characteristics of opioids and Comments submitted in response to treating employment-related injuries compounded drugs authorized by the this notice will be summarized and/or under the Federal Employees FECA program. The forms will serve as included in the request for Office of Compensation Act (FECA), 5 U.S.C. a means for injured workers to continue Management and Budget approval of the 8101 et seq. receiving opioids and compounded information collection request; they will The FECA statute grants OWCP also become a matter of public record. drugs only where medically necessary discretion to provide an injured and simultaneously give OWCP greater Dated: June 16, 2016. employee the ‘‘services, appliances, and oversight in monitoring their Yoon Ferguson, supplies prescribed or recommended by appropriate use and gather additional Agency Clearance Officer, Office of Workers’ a qualified physician’’ which OWCP data about their use. Compensation Programs, U.S. Department of considers ‘‘likely to cure, give relief, reduce the degree or the period of II. Review Focus Labor. disability, or aid in lessening the [FR Doc. 2016–14818 Filed 6–21–16; 8:45 am] The Department of Labor is amount of the monthly compensation.’’ particularly interested in comments BILLING CODE 4510–CH–P 5 U.S.C. 8103. In other words, OWCP is which: mandated to provide medical supplies • Evaluate whether the proposed DEPARTMENT OF LABOR and services—including prescription collection of information is necessary drugs such as opioids and compounded for the proper performance of the Office of Workers’ Compensation drugs—that it considers medically functions of the agency, including Programs necessary. 20 CFR 10.310. The FECA whether the information will have statute and implementing regulations practical utility; Advisory Board on Toxic Substances are not primarily focused on managing • evaluate the accuracy of the and Worker Health: Subcommittee on doctor/patient decisions relating to agency’s estimate of the burden of the Medical Advice re: Weighing Medical medication therapy and, with the proposed collection of information, Evidence exception of few limitations on fentanyl including the validity of the (an opioid) and other controlled AGENCY: Office of Workers’ mstockstill on DSK3G9T082PROD with NOTICES methodology and assumptions used; substances, the FECA program policy on • enhance the quality, utility and Compensation Programs, Labor. pharmacy benefits has generally been a clarity of the information to be ACTION: Announcement of meeting of policy of payment for prescribed collected; and the Subcommittee on Medical Advice medications in accordance with a fee • minimize the burden of the re: Weighing Medical Evidence of the schedule based on a percentage of the collection of information on those who Advisory Board on Toxic Substances average wholesale price (AWP) for drugs are to respond, including through the and Worker Health (Advisory Board) for identified by a National Drug Code use of appropriate automated, the Energy Employees Occupational VerDate Sep<11>2014 20:02 Jun 21, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1


Document Created: 2016-06-22 01:06:15
Document Modified: 2016-06-22 01:06:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesWritten comments must be submitted to the office listed in the
FR Citation81 FR 40721 
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