Agency Information Collection Activities: Proposed Collection; Comment Request, 14372-14373 [2017-05419]

Download as PDF 14372 Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices checking the appropriate box(es) to indicate what information FDA may publish on the Web site. The reporting burden in table 5 includes only the time necessary to fill out and send the form, as compiling the underlying information (including selfassessment reports, Risk Factor Study data collection, outside audits, and supporting documentation) is accounted for under the recordkeeping estimates in table 4. FDA estimates the reporting burden for this collection of information as follows: TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Average burden per response (hours) Total annual responses Activity FDA form Submission of ‘‘FDA National Registry Report’’. Request for documentation of successful completion of staff training. 3598 .................................. 500 1 500 0.1 (6 minutes) 50 Conference for Food Protection Training Plan and Log. 500 3 1,500 0.1 (6 minutes) 150 Total ........................... ........................................... ........................ ........................ ........................ ........................... 200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimates of the number of respondents and the hours per response on its experience with the Program Standards. As explained previously in this document, FDA estimates that no more than 500 Regulatory jurisdictions will participate in the Program Standards in any given year. FDA estimates a total of 6 minutes annually for each enrolled jurisdiction to complete the form. FDA bases its estimate on the small number of data elements on the form and the ease of availability of the information. FDA estimates that, annually, 500 regulatory jurisdictions will submit one Form FDA 3598 for a total of 500 annual responses. Each submission is estimated to take 0.1 hour (or 6 minutes) per response for a total of 50 hours. In addition, FDA estimates that, annually, 500 regulatory jurisdictions will submit three requests for documentation of successful completion of staff training using the CFP Training Plan and Log for a total of 1,500 annual responses. Each submission is estimated to take 0.1 hour (or 6 minutes) per response for a total of 150 hours. Thus, the total reporting burden for this information collection is 200 hours. Dated: March 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–05414 Filed 3–17–17; 8:45 am] BILLING CODE 4164–01–P sradovich on DSK3GMQ082PROD with NOTICES Total hours VerDate Sep<11>2014 18:36 Mar 17, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Proposed Project: Notification of Intent To Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’—(OMB No. 0930–0369)— Revision The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting a revision from the Office of Management and Budget (OMB) for approval of the Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner. The Notification of Intent would allow SAMHSA to determine whether other practitioners are eligible to prescribe certain approved narcotic treatment medications for the maintenance or detoxification treatment of opioid addiction. This Notification of Intent is a result of the Comprehensive Addiction and Recovery Act (Pub. L. 114–198), which was signed into law on July 22, 2016. The law establishes criteria for nurse practitioners (NPs) and physician assistants (PAs) to qualify for a waiver to prescribe covered medications. To be eligible for a waiver, the NP or PA must: Be licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain; fulfill qualification requirements in the law for training and experience; and fulfill qualification requirements in the law for appropriate supervision by a qualifying physician. SAMHSA has the responsibility to receive, review, approve, or deny waiver requests. Practitioners who meet the statutory requirements will be eligible to prescribe only those opioid treatment medications that are controlled in Schedules III, IV, or V, under the E:\FR\FM\20MRN1.SGM 20MRN1 14373 Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices Controlled Substance Act (CSA), that are specifically approved by the Food and Drug Administration (FDA) for the treatment of opioid addiction, and are not the subject of an ‘‘adverse determination.’’ The only medications that currently fulfill these requirements are ones that contain the active ingredient buprenorphine. Below are the following changes: Use of Term of ‘‘Qualifying Practitioners’’ (NOI Sections 1, 2, 6, and 11) The Statute Section 823(g)(2)(B)(i) refers to both physicians and mid-level providers as ‘‘qualifying practitioners.’’ Therefore in order to avoid confusion and redundancy, the revised NOI refers to ‘‘other qualifying practitioners,’’ simply as ‘‘practitioners’’. Patient Limits (See NOI Section 6: Purpose of Notification) Language was added allowing practitioners who have treated 30 Number of respondents Purpose of submission Notification of Intent for Qualifying Other Practitioner to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’ under 21 USC § 823(g)(2)—Nurse Practitioners .................................................................. Notification of Intent for Qualifying Other Practitioner to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’ under 21 USC § 823(g)(2)—Physician Assistants ............................................................... Total .......................................................................................................... Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57–B, Rockville, Maryland 20857, OR email a copy to summer.king@samhsa.hhs.gov. Written comments should be received by May 19, 2017. Summer King, Statistician. [FR Doc. 2017–05419 Filed 3–17–17; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory. AGENCY: sradovich on DSK3GMQ082PROD with NOTICES CBPL No. patients for at least one year to increase their patient limit to 100. This second notification to treat 100 patients was omitted in the original NOI form. Identification of Training Providers The previous NOI required that the practitioner to write in the name of training provider(s)’ name(s). The revised NOI allows practitioners to select training providers from a list. The following table is the estimated hour burden: Responses/ respondent Burden hours Total burden hours 816 1 .066 54 590 1 .066 39 1,406 ........................ ........................ 93 Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of May 26, 2016. DATES: The accreditation and approval of Camin Cargo Control, Inc., as commercial gauger and laboratory became effective on May 26, 2016. The next triennial inspection date will be scheduled for May 2019. FOR FURTHER INFORMATION CONTACT: Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202– 344–1060. SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 31 Fulton St. Unit A, New Haven, CT 06513, has been approved to gauge and accredited to test petroleum and certain petroleum products for SUMMARY: customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API): API chapters 1 ................... 3 ................... 7 ................... 8 ................... 11 ................. 12 ................. 17 ................. Title Vocabulary. Tank gauging. Temperature Determination. Sampling. Physical Properties Data. Calculations. Maritime Measurements. Camin Cargo Control, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM): ASTM Title ............. ............. ............. ............. D287 D86 D445 D4294 27–20 ............. 27–48 ............. 27–50 ............. D4057 D4052 D93 Standard Test Method for API Gravity of crude Petroleum and Petroleum Products Standard Test Method for Distillation of Petroleum Products Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence Spectrometry Standard Practice for Manual Sampling of Petroleum and Petroleum Products Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester 27–01 27–08 27–11 27–13 VerDate Sep<11>2014 18:36 Mar 17, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1

Agencies

[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14372-14373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05419]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-1243.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Notification of Intent To Use Schedule III, IV, or V 
Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate 
Addiction by a ``Qualifying Other Practitioner''--(OMB No. 0930-0369)--
Revision

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is requesting a revision from the Office of Management and 
Budget (OMB) for approval of the Notification of Intent to Use Schedule 
III, IV, or V Opioid Drugs for the Maintenance and Detoxification 
Treatment of Opiate Addiction by a ``Qualifying Other Practitioner. The 
Notification of Intent would allow SAMHSA to determine whether other 
practitioners are eligible to prescribe certain approved narcotic 
treatment medications for the maintenance or detoxification treatment 
of opioid addiction.
    This Notification of Intent is a result of the Comprehensive 
Addiction and Recovery Act (Pub. L. 114-198), which was signed into law 
on July 22, 2016. The law establishes criteria for nurse practitioners 
(NPs) and physician assistants (PAs) to qualify for a waiver to 
prescribe covered medications. To be eligible for a waiver, the NP or 
PA must: Be licensed under State law to prescribe schedule III, IV, or 
V medications for the treatment of pain; fulfill qualification 
requirements in the law for training and experience; and fulfill 
qualification requirements in the law for appropriate supervision by a 
qualifying physician. SAMHSA has the responsibility to receive, review, 
approve, or deny waiver requests.
    Practitioners who meet the statutory requirements will be eligible 
to prescribe only those opioid treatment medications that are 
controlled in Schedules III, IV, or V, under the

[[Page 14373]]

Controlled Substance Act (CSA), that are specifically approved by the 
Food and Drug Administration (FDA) for the treatment of opioid 
addiction, and are not the subject of an ``adverse determination.'' The 
only medications that currently fulfill these requirements are ones 
that contain the active ingredient buprenorphine.
    Below are the following changes:

Use of Term of ``Qualifying Practitioners'' (NOI Sections 1, 2, 6, and 
11)

    The Statute Section 823(g)(2)(B)(i) refers to both physicians and 
mid-level providers as ``qualifying practitioners.'' Therefore in order 
to avoid confusion and redundancy, the revised NOI refers to ``other 
qualifying practitioners,'' simply as ``practitioners''.

Patient Limits (See NOI Section 6: Purpose of Notification)

    Language was added allowing practitioners who have treated 30 
patients for at least one year to increase their patient limit to 100. 
This second notification to treat 100 patients was omitted in the 
original NOI form.

Identification of Training Providers

    The previous NOI required that the practitioner to write in the 
name of training provider(s)' name(s). The revised NOI allows 
practitioners to select training providers from a list.
    The following table is the estimated hour burden:

----------------------------------------------------------------------------------------------------------------
                                                     Number of      Responses/                     Total burden
              Purpose of submission                 respondents     respondent     Burden hours        hours
----------------------------------------------------------------------------------------------------------------
Notification of Intent for Qualifying Other                  816               1            .066              54
 Practitioner to Use Schedule III, IV, or V
 Opioid Drugs for the Maintenance and
 Detoxification Treatment of Opiate Addiction by
 a ``Qualifying Other Practitioner'' under 21
 USC Sec.   823(g)(2)--Nurse Practitioners......
Notification of Intent for Qualifying Other                  590               1            .066              39
 Practitioner to Use Schedule III, IV, or V
 Opioid Drugs for the Maintenance and
 Detoxification Treatment of Opiate Addiction by
 a ``Qualifying Other Practitioner'' under 21
 USC Sec.   823(g)(2)--Physician Assistants.....
                                                                 -----------------------------------------------
    Total.......................................           1,406  ..............  ..............              93
----------------------------------------------------------------------------------------------------------------

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a 
copy to summer.king@samhsa.hhs.gov. Written comments should be received 
by May 19, 2017.

Summer King,
Statistician.
[FR Doc. 2017-05419 Filed 3-17-17; 8:45 am]
 BILLING CODE 4162-20-P