83 FR 49400 - Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 190 (October 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 190 (October 1, 2018)
| Page Range | 49400-49403 | |
| FR Document | 2018-21314 |
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)] [Notices] [Pages 49400-49403] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21314] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3124] Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The draft guidance will replace the 2010 draft guidance for industry entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' DATES: Submit either electronic or written comments on the draft guidance by November 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-3124 for ``Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301- 794-2055; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This document provides guidance to sponsors and applicants submitting INDs, NDAs, BLAs, or supplemental applications on the appropriate use of adaptive designs [[Page 49401]] for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The guidance also advises sponsors on the types of information FDA needs to evaluate the results from clinical trials with adaptive designs, including Bayesian adaptive designs and complex designs that rely on computer simulations for their design. This guidance meets FDA's performance commitment under PDUFA (Prescription Drug User Fee Act) VI to publish draft guidance on complex adaptive (including Bayesian adaptive) trial designs by the end of fiscal year 2018. The primary focus of this guidance is on adaptive designs for clinical trials intended to support the effectiveness and safety of drugs or biologics. The concepts discussed are also useful for early phase or exploratory clinical trials as well as trials conducted to satisfy postmarketing commitments or requirements. The draft guidance will replace the 2010 draft guidance for industry entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501- 3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this draft guidance, FDA invites comments on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. The draft guidance discusses several collections of information that have been approved by OMB. For example, the draft guidance explains that sponsors who have questions about adaptive design elements in an early-phase exploratory trial should seek FDA feedback by either identifying specific questions in a submission containing the protocol or by requesting a meeting to discuss those questions. Discussion of the plans for an adaptive trial can be the basis for requesting a Type C meeting. Regulatory mechanisms for obtaining formal, substantive feedback from FDA on clinical trials may also include end-of-phase 2 meetings. The draft guidance also recommends that special protocol assessments (given the 45-day response timeline) are submitted for trials with complex adaptive designs only if there has been extensive previous discussion between FDA and the sponsor regarding the proposed trial and design. The draft guidance explains that in their submissions, the sponsors should pre-specify the details of the adaptive design and provide justification that the chances of erroneous conclusions will be adequately controlled, estimation of treatment effects will be sufficiently reliable, and trial integrity will be appropriately maintained. The draft guidance notes that the sponsor should advise FDA during the course of a trial of any proposed changes to the trial design (usually through protocol amendments), and that FDA may request that the sponsor submit minutes from open sessions of a monitoring committee during an ongoing trial. FDA has OMB approval under the PRA for the submission of INDs, including protocol amendments and information amendments, in 21 CFR part 312, subpart B, and sponsors may request comment and advice on an IND as well as request meetings with FDA under subpart C (OMB control number 0910-0014). In addition, the following collections of information that have been approved by OMB would cover other submissions discussed in the draft guidance: Guidance for industry on formal meetings with sponsors and applicants for PDUFA products (OMB control number 0910-0429); Guidance for Industry on special protocol assessment (OMB control number 0910-0470); Guidance for industry on clinical trial data monitoring committees (OMB control number 0910-0581); Guidance for industry on oversight of clinical investigations (OMB control number 0910-0733); International Council for Harmonization guidance for industry ``E6(R2) Good Clinical Practice'' (OMB control number 0910- 0843); Protection of Human Subjects: Informed Consent; Institutional Review Boards (21 CFR parts 50 and 56) (OMB control number 0910-0755); Institutional Review Boards (21 CFR 56.115) (OMB control number 0910-0130); and Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (OMB control number 0910- 0572). In addition, the submission of NDAs, including 21 CFR 314.50(d)(5) (clinical data section) and (d)(6) (statistical section), has been approved under OMB control number 0910-0001. The submission of BLAs and their supplements has been approved under OMB control number 0910-0338. The draft guidance also requests the submission of information that has not been approved by OMB under the PRA. In section VIII.B, the draft guidance states that the documented plan for a clinical trial with a proposed adaptive design should include the information described below. The information could be included in the clinical trial protocol and/or in separate documents, such as a statistical analysis plan, a data monitoring committee (DMC) charter, or an adaptation committee charter. Although different types of information might be included in different documents, all important information described below should be submitted to FDA during the design stage so that FDA has sufficient time to provide feedback prior to initiation of the clinical trial: A rationale for the selected design; A detailed description of the monitoring and adaptation plan, including the anticipated number and [[Page 49402]] timing of interim analyses, the specific aspects of the design that may be modified, and the specific rule that will be used to make adaptation decisions; Information on the roles of the bodies responsible for implementing the adaptive design, such as the DMC and/or the dedicated adaptation committee; Pre-specification of the statistical methods that will be used to produce interim results and guide adaptation decisions, and to carry out hypothesis tests, estimate treatment effects, and estimate uncertainty in treatment effect estimates at the end of the trial; Evaluation and discussion of the design operating characteristics; When simulations are the primary or sole technique for evaluating trial operating characteristics, a detailed simulation report should be submitted, including: [cir] An overall description of the trial design; [cir] Example trials, in which a small number of hypothetical trials are described with different conclusions, such as a positive trial with the original sample size, a trial stopped for futility after the first interim look, a positive trial after increasing the sample size; [cir] A description of the set of parameter configurations used for the simulation scenarios, including a justification of the adequacy of the choices; [cir] Simulation results detailing the estimated Type I error probability and power under the various scenarios; [cir] Simulation code that is readable and adequately commented and should include the random seeds used to generate the simulation results; [cir] A summary providing overall conclusions. A comprehensive written data access plan defining how trial integrity will be maintained in the presence of the planned adaptations. This documentation should include the following information: (1) The personnel who will perform the interim analyses; (2) the personnel who will have access to interim results; (3) how that access will be controlled; (4) how adaptive decisions will be made; and (5) what type of information will be disseminated following adaptive decisions, and to whom it will be disseminated. The data access plan should describe what information, under what circumstances, is permitted to be passed to the sponsor or investigators. In addition, it is recommended that sponsors establish procedures to evaluate compliance with the data access plan and to document all interim meetings of the committee tasked with making adaptation decisions, i.e., the DMC or other adaptation committee (e.g., with written minutes describing what was reviewed, discussed, and decided). In section VIII.C, the draft guidance states that a marketing application to FDA that relies on a trial with an adaptive design should include, in addition to the typical content of that marketing application, sufficient information and documentation to allow FDA to thoroughly review the results, including: All prospective plans, any relevant committee charters (e.g., the DMC or adaptation committee charter), and any supporting documentation (e.g., literature references, programming code, simulation report); Information on compliance with the planned adaptation rule and with the procedures outlined in the data access plan to maintain trial integrity; Records of deliberations and participants for any interim discussions by any committees involved in the adaptive process; Results of the interim analyses used for the adaptation decisions; Appropriate reporting of the adaptive design and trial results in the proposed package insert. For example, the trial summary should describe the adaptive design utilized. In addition, treatment effect estimates should appropriately take the design into account, or if na[iuml]ve estimates such as unadjusted sample means are used, the extent of bias should be evaluated and estimates should be presented with appropriate cautions regarding their interpretation. Based on our review of INDs, NDAs, BLAs, and supplemental applications for the use of adaptive designs for clinical trials to provide evidence of effectiveness and safety, we estimate that approximately 40 sponsors or applicants (``number of respondents'' in table 1, row 1) will prepare approximately 240 documented plans for clinical trials containing a proposed adaptive design and analysis plan and will submit this information to FDA in a clinical trial protocol and/or in separate documents such as a statistical analysis plan, a DMC charter, or an adaptation committee charter (``total annual responses'' in table 1, row 1), and that preparing and submitting this information will take approximately 50 hours per sponsor or applicant (``average burden per response'' in table 1, row 1). In addition, we estimate that approximately 15 sponsors or applicants (``number of respondents'' in table 1, row 2) will prepare and submit to FDA approximately 20 marketing applications that rely on a trial with an adaptive design (``total annual responses'' in table 1, row 2), and that preparing and submitting this information will take approximately 50 hours per sponsor or applicant (``average burden per response'' in table 1, row 2). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Guidance on adaptive designs for Number of Average clinical trials of drugs and Number of responses per Total annual burden per Total hours biologics respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Clinical trial protocols and 40 6 240 50 12,000 related submissions to FDA with an adaptive design and analysis plan should contain the information in section VIII.B.. Marketing applications that rely 15 1.33 20 50 1,000 on studies with an adaptive design should contain the information in section VIII.C.. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 13,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 49403]] III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: September 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21314 Filed 9-28-18; 8:45 am] BILLING CODE 4164-01-P
![49400 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
Dated: September 25, 2018. confidential business information, such as ‘‘confidential’’ will not be disclosed
Leslie Kux, as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Associate Commissioner for Policy. that if you include your name, contact and other applicable disclosure law. For
[FR Doc. 2018–21313 Filed 9–28–18; 8:45 am] information, or other information that more information about FDA’s posting
BILLING CODE 4164–01–P identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
DEPARTMENT OF HEALTH AND • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
Food and Drug Administration public, submit the comment as a read background documents or the
[Docket No. FDA–2018–D–3124]
written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to https://
Adaptive Designs for Clinical Trials of Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Drugs and Biologics; Draft Guidance Written/Paper Submissions docket number, found in brackets in the
for Industry; Availability heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, follows: and/or go to the Dockets Management
HHS. • Mail/Hand delivery/Courier (for
Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice of availability. written/paper submissions): Dockets
Rockville, MD 20852.
Management Staff (HFA–305), Food and
SUMMARY: The Food and Drug You may submit comments on any
Drug Administration, 5630 Fishers
Administration (FDA or Agency) is guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
announcing the availability of a draft • For written/paper comments 10.115(g)(5)).
guidance for industry entitled submitted to the Dockets Management Submit written requests for single
‘‘Adaptive Designs for Clinical Trials of Staff, FDA will post your comment, as copies of the draft guidance to the
Drugs and Biologics.’’ This document well as any attachments, except for Division of Drug Information, Center for
provides guidance to sponsors and information submitted, marked and Drug Evaluation and Research, Food
applicants submitting investigational identified, as confidential, if submitted and Drug Administration, 10001 New
new drug applications (INDs), new drug as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
applications (NDAs), biologics license Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
applications (BLAs), or supplemental must include the Docket No. FDA– 0002; or to the Office of
applications on the appropriate use of 2018–D–3124 for ‘‘Adaptive Designs for Communication, Outreach and
adaptive designs for clinical trials to Clinical Trials of Drugs and Biologics; Development, Center for Biologics
provide evidence of the effectiveness Draft Guidance for Industry.’’ Received Evaluation and Research, Food and
and safety of a drug or biologic. The comments will be placed in the docket Drug Administration, 10903 New
guidance describes the basic principles and, except for those submitted as Hampshire Ave., Bldg. 71, Rm. 3128,
for designing, conducting, and reporting ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002. Send
the results from an adaptive clinical viewable at https://www.regulations.gov one self-addressed adhesive label to
trial. The draft guidance will replace the or at the Dockets Management Staff assist that office in processing your
2010 draft guidance for industry entitled office between 9 a.m. and 4 p.m., requests. The guidance may also be
‘‘Adaptive Design Clinical Trials for Monday through Friday. obtained by mail by calling CBER at 1–
Drugs and Biologics.’’ • Confidential Submissions—To 800–835–4709 or 240–402–8010. See
DATES: Submit either electronic or submit a comment with confidential the SUPPLEMENTARY INFORMATION section
written comments on the draft guidance information that you do not wish to be for electronic access to the draft
by November 30, 2018 to ensure that the made publicly available, submit your guidance document.
Agency considers your comment on this comments only as a written/paper FOR FURTHER INFORMATION CONTACT:
draft guidance before it begins work on submission. You should submit two Scott Goldie, Center for Drug Evaluation
the final version of the guidance. copies total. One copy will include the and Research, Food and Drug
ADDRESSES: You may submit comments information you claim to be confidential Administration, 10903 New Hampshire
on any guidance at any time as follows: with a heading or cover note that states Ave., Bldg. 21, Rm. 3557, Silver Spring,
‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–794–2055; or
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The Stephen Ripley, Center for Biologics
Submit electronic comments in the Agency will review this copy, including Evaluation and Research, Food and
following way: the claimed confidential information, in Drug Administration, 10903 New
• Federal eRulemaking Portal: its consideration of comments. The Hampshire Ave., Bldg. 71, Rm. 7301,
https://www.regulations.gov. Follow the second copy, which will have the Silver Spring, MD 20993–0002, 240–
instructions for submitting comments. claimed confidential information 402–7911.
Comments submitted electronically, redacted/blacked out, will be available SUPPLEMENTARY INFORMATION:
including attachments, to https:// for public viewing and posted on
www.regulations.gov will be posted to https://www.regulations.gov. Submit I. Background
the docket unchanged. Because your both copies to the Dockets Management FDA is announcing the availability of
amozie on DSK3GDR082PROD with NOTICES
comment will be made public, you are Staff. If you do not wish your name and a draft guidance for industry entitled
solely responsible for ensuring that your contact information to be made publicly ‘‘Adaptive Designs for Clinical Trials of
comment does not include any available, you can provide this Drugs and Biologics.’’ This document
confidential information that you or a information on the cover sheet and not provides guidance to sponsors and
third party may not wish to be posted, in the body of your comments and you applicants submitting INDs, NDAs,
such as medical information, your or must identify this information as BLAs, or supplemental applications on
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked the appropriate use of adaptive designs
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![Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 49403
III. Electronic Access substance abuse treatment and mental Qualified Health Centers (FQHC);
Persons with access to the internet health treatment facilities known to Disulfiram, Naltrexone, or Acamprosate
may obtain the draft guidance at https:// SAMHSA. (The N–MHSS data for alcohol use disorder for outpatient,
www.regulations.gov, http:// collection is covered under OMB No. inpatient, and residential. Also,
www.fda.gov/Drugs/Guidance 0930–0119.) response categories were added to select
ComplianceRegulatoryInformation/ The information in I–BHS and that services are not provided, and for
Guidances/default.htm, or http:// N–SSATS is needed to assess the nature medication services provided, an
www.fda.gov/BiologicsBloodVaccines/ and extent of these resources, to identify ‘‘other’’ category was added.
GuidanceComplianceRegulatory gaps in services, and to provide a The following items have been
Information/Guidances/default.htm. database for treatment referrals. Both deleted compared to the 2017
I–BHS and N–SSATS are components of N–SSATS: Questions about religious
Dated: September 25, 2018. the Behavioral Health Services affiliation, standard operating
Leslie Kux, Information System (BHSIS). procedures, outpatient capacity, how
Associate Commissioner for Policy. The request for OMB approval will (paper/electronic/both) a facility
[FR Doc. 2018–21314 Filed 9–28–18; 8:45 am] include a request to update the I–BHS performs selected activities, and the
BILLING CODE 4164–01–P facility listing on a continuous basis and item asking about Access To Recovery
to conduct the N–SSATS and the (ATR) client payments have been
between cycle N–SSATS (N–SSATS BC) deleted.
DEPARTMENT OF HEALTH AND in 2019, 2020, and 2021. The N–SSATS The following additional changes
HUMAN SERVICES BC is a procedure for collecting services have been made compared to the 2017
data from newly identified facilities N–SSATS: Removed the asterisk from
Substance Abuse and Mental Health between main cycles of the survey and the question about primary focus of
Services Administration will be used to improve the listing of facilities, which means the information
treatment facilities in the online will no longer be published on the
Agency Information Collection N–SSATS treatment locator; reorganized
Behavioral Health Treatment Services
Activities: Submission for OMB the question about services offered;
Locator.
Review; Comment Request moved the question on types of
Planned Changes counseling to the question about
Periodically, the Substance Abuse and
Mental Health Services Administration I–BHS: Only minor form changes services offered; changed the wording
(SAMHSA) will publish a summary of corresponding with updated technology from Screening for Hepatitis B and C to
information collection requests under are planned. Testing for Hepatitis B and C; changed
OMB review, in compliance with the N–SSATS: The N–SSATS with client ‘‘Screening for mental health disorders’’
Paperwork Reduction Act (44 U.S.C. counts will continue to be conducted in to ‘‘Screening for mental disorders’’;
Chapter 35). To request a copy of these alternate years, as in the past, and the changed the question about clinical/
documents, call the SAMHSA Reports Treatment Locator will be updated therapeutic approaches to a ‘‘mark all
Clearance Officer on (240) 276–1243. monthly. that apply’’ format; changed the
Version A (2019 and 2021) wording from ‘‘Computerized substance
Project: National Survey of Substance abuse treatment/telemedicine’’ to
Abuse Treatment Services (N–SSATS) The following items have been added ‘‘Telemedicine/telehealth’’; changed the
(OMB No. 0930–0106)—Revision compared to the 2017 N–SSATS: Add question wording about the number of
The Substance Abuse and Mental questions about: Where clients obtain outpatient clients so it states, ‘‘As of
Health Services Administration their medications for opioid use March 29, 2019, how many active
(SAMHSA) is requesting a revision of disorder if they originate elsewhere; clients were receiving each of the
the National Survey of Substance Abuse how facilities treat alcohol use disorder; following outpatient substance abuse
Treatment (N–SSATS) data collection where clients obtain their medications services at this facility?’’ and changed
(OMB No. 0930–0106), which expires for alcohol use disorder if they originate the instructions to state ‘‘An active
on December 31, 2018. N–SSATS elsewhere; whether the facility only client is a client who received treatment
provides both national and state-level treats alcohol use disorder; in March and is still enrolled in
data on the numbers and types of detoxification from opioids of abuse treatment on March 29, 2019.’’; and
patients treated and the characteristics with lofexidine or clonidine; the percent changed the question about halfway
of facilities providing substance abuse of clients on MAT for opioid use houses so it states, ‘‘Does this facility
treatment services. It is conducted disorder that receive maintenance operate transitional housing, a halfway
under the authority of Section 505 of the services, detoxification, and relapse house, or a sober home for substance
Public Health Service Act (42 U.S.C. prevention; testing for metabolic abuse clients at this location, that is, the
290aa-4) to meet the specific mandates syndrome; drug and alcohol oral fluid location listed on the front cover?’’
for annual information about public and testing; professional interventionist/ For the question about how facilities
private substance abuse treatment educational consultant; recovery coach; treat opioid use disorder, information
providers and the clients they serve. vocational training or educational was added about the question that
This request includes: support; Naloxone and overdose states, ‘‘For this question, MAT refers to
• Collection of N–SSATS, which is an education; ‘‘Outcome follow-up after any or all of these medications unless
annual survey of substance abuse discharge’’ which was moved from specified.’’ Also, category 5 was
treatment facilities; and another question; medications for HIV reworded to say ‘‘This facility
amozie on DSK3GDR082PROD with NOTICES
• Updating of the Inventory of treatment; medications for Hepatitis C administers naltrexone to treat opioid
Behavioral Health Services (I–BHS) treatment; the medications lofexidine use disorder. Naltrexone use is
which is the facility universe for the and clonidine; Hepatitis A and B authorized through any medical staff
N–SSATS as well as the annual survey vaccinations; Buprenorphine (extended- who have prescribing privileges.’’ In
of mental health treatment facilities, the release, injectable, for example, addition, a category was added, ‘‘This
National Mental Health Services Survey Sublocade®)’’; clients with co-occurring facility prescribes buprenorphine to
(N–MHSS). The I–BHS includes all pain and substance use; Federally treat opioid use disorder.
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Document Created: 2018-09-29 04:26:27
Document Modified: 2018-09-29 04:26:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by November 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301- 794-2055; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 49400 |
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