83_FR_23081 83 FR 22985 - Agency Information Collection Request. 30-Day Public Comment Request

83 FR 22985 - Agency Information Collection Request. 30-Day Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 96 (May 17, 2018)

Page Range22985-22986
FR Document2018-10512

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Federal Register, Volume 83 Issue 96 (Thursday, May 17, 2018) 
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22985-22986]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-new]


Agency Information Collection Request. 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before June 18, 2018.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected] 
or (202) 795-7714. When submitting comments or requesting information, 
please include the document identifier 0990-New-30D and project title 
for reference.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Title of the Collection: Evaluation of the Assisted Outpatient 
Treatment Grant Program for Individuals with Serious Mental Illness.
    Type of Collection: New.
    Abstract: The Office of the Assistant Secretary for Planning and 
Evaluation (ASPE) at the U.S. Department of Health and Human Services 
(HHS) is requesting Office of Management and Budget (OMB) approval for 
data collection activities to support the evaluation of the Substance 
Abuse and Mental Health Services Administration's (SAMHSA's) Assisted 
Outpatient Treatment (AOT) Grant Program for Individuals with Serious 
Mental Illness (SM-16-011). Enacted into law on April 1, 2014, Section 
224 of the Protecting Access to Medicare Act (PAMA) (Pub. L. 113-93) 
mandated a 4-year pilot program of grants to implement AOT programs 
nationwide. Section 224(e) required a program evaluation to examine the 
impact of AOT on cost savings and public health outcomes, 
incarceration, homelessness, and patient and family satisfaction with 
program participation.
    Focusing specifically on six of the 17 sites, the in-depth 
implementation and outcome evaluation of the SAMHSA AOT Grant Program 
for Individuals with Serious Mental Illness is being carried out by RTI 
International, in partnership with Duke University and Policy Research 
Associates. The completed implementation evaluation, conducted from 
November 2016 to August 2017, gathered information related to the 
processes and practices of AOT across the six in-depth sites. The 
information to be collected for the outcome evaluation will allow ASPE 
and partners SAMHSA and NIMH to assess which elements of AOT programs 
influence health and social outcomes for people under AOT orders, as 
well as the use of services, associated costs, and patient and family 
satisfaction with the AOT process.
    Need and Proposed Use of the Information: Section 224(e) of PAMA 
requires annual reports to Congress that include evaluation of: Cost 
savings and

[[Page 22986]]

public health outcomes such as mortality, suicide, substance abuse, 
hospitalization, and use of services; rates of incarceration by 
patients; rates of homelessness among patients; and patient and family 
satisfaction with program participation. The data collected under this 
submission will help ASPE address the evaluation questions listed above 
and inform the required reports to Congress.

                             Total Estimated Annualized Burden Hours to Respondents
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
             Forms                 Respondents       Number of     responses per   per response    Total annual
                                                    respondents     respondent        (hours)     burden (hours)
----------------------------------------------------------------------------------------------------------------
Client Interview Instrument...  Program                      520               3            1.00         1560.00
                                 Participant.
                                Comparison                   520               3            1.00         1560.00
                                 Subjects.
Family Satisfaction Survey....  Program                      173               1           15/60           43.25
                                 Participant's
                                 Family Member.
Cost Questionnaire............  Program                        6               1            1.25            7.50
                                 Administrator.
                                Other Site                    12               1            1.25           15.00
                                 Representatives.
Docket Case Monitoring Form...  AOT Local                      6             390            6/60          234.00
                                 Evaluator.
AOT Characteristics Form......  AOT Local                      6              12           30/60           36.00
                                 Evaluator.
                                                 ---------------------------------------------------------------
    Total.....................  ................           1,243             411            0.76        3,455.75
----------------------------------------------------------------------------------------------------------------


Terry Clark,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. 2018-10512 Filed 5-16-18; 8:45 am]
BILLING CODE 4150-05-P

Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices 22985 technologies as our resources permit. a fee of up to $175 if the Agency issues product type, but it will not exceed FDA notes section 801 of the Federal a certificate within 20 days of receipt of $175. Food, Drug, and Cosmetic Act (21 U.S.C. a complete request for such a certificate. We estimate the burden of the 381) also provides that FDA may charge This fee may vary depending on the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average burden per Number of Total annual Type of respondent FDA Form No.2 responses per response Total hours respondents responses respondent (in hours) Cosmetics ..................... 3613d .......................... 270 3 810 0.5 (30 minutes) .......... 405 Food ............................. 3613e, 3613g, 3613l ... 881 5 4,405 0.5 (30 minutes) .......... 2,203 Total ...................... ..................................... ........................ ........................ ........................ ..................................... 2,608 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 All forms are submitted electronically via CAP. This estimate reflects a revision DEPARTMENT OF HEALTH AND Type of Collection: New. resulting from the elimination of paper- HUMAN SERVICES Abstract: The Office of the Assistant based forms. Specifically, and based on Secretary for Planning and Evaluation [Document Identifier: OS–0990–new] (ASPE) at the U.S. Department of Health our experience with the information collection, we have reduced the and Human Services (HHS) is Agency Information Collection estimated time to prepare a submission requesting Office of Management and Request. 30-Day Public Comment from 1.5 hours to 0.5 hour. The previous Budget (OMB) approval for data Request estimate was based on the time collection activities to support the AGENCY: Office of the Secretary, HHS. evaluation of the Substance Abuse and necessary to prepare a paper ACTION: Notice. Mental Health Services submission, but all firms requesting Administration’s (SAMHSA’s) Assisted export certificates now provide SUMMARY: In compliance with the Outpatient Treatment (AOT) Grant submissions electronically via CAP. We requirement of the Paperwork Program for Individuals with Serious believe that the time to prepare an Reduction Act of 1995, the Office of the Mental Illness (SM–16–011). Enacted electronic submission is under 0.25 Secretary (OS), Department of Health into law on April 1, 2014, Section 224 hour, but are estimating 0.5 hour as a and Human Services, is publishing the of the Protecting Access to Medicare Act conservative approach to address all following summary of a proposed (PAMA) (Pub. L. 113–93) mandated a 4- scenarios. We base our estimates of the collection for public comment. year pilot program of grants to total annual responses on our DATES: Comments on the ICR must be implement AOT programs nationwide. experience with certificate applications received on or before June 18, 2018. Section 224(e) required a program received in the past 3 fiscal years. ADDRESSES: Submit your comments to evaluation to examine the impact of We expect that most firms requesting OIRA_submission@omb.eop.gov or via AOT on cost savings and public health export certificates in the next 3 years facsimile to (202) 395–5806. outcomes, incarceration, homelessness, and patient and family satisfaction with will choose to take advantage of the FOR FURTHER INFORMATION CONTACT: program participation. option of electronic submission via Sherrette Funn, Sherrette.Funn@hhs.gov Focusing specifically on six of the 17 CAP. If a firm is unable to submit their or (202) 795–7714. When submitting sites, the in-depth implementation and information via CAP, they may contact comments or requesting information, outcome evaluation of the SAMHSA CFSAN and request assistance. CFSAN please include the document identifier AOT Grant Program for Individuals with will assist firms in entering their 0990–New–30D and project title for Serious Mental Illness is being carried information into the electronic system reference. out by RTI International, in partnership so that the firm may receive their export SUPPLEMENTARY INFORMATION: Interested with Duke University and Policy certificates in a timely manner. Our persons are invited to send comments Research Associates. The completed burden estimates in table 1 are based on regarding this burden estimate or any implementation evaluation, conducted the expectation of 100 percent other aspect of this collection of from November 2016 to August 2017, participation in the electronic information, including any of the gathered information related to the submission process. Providing the following subjects: (1) The necessity and processes and practices of AOT across opportunity to submit the information utility of the proposed information the six in-depth sites. The information in electronic format has reduced our collection for the proper performance of to be collected for the outcome previous estimates for the time to the agency’s functions; (2) the accuracy evaluation will allow ASPE and prepare each submission. of the estimated burden; (3) ways to partners SAMHSA and NIMH to assess enhance the quality, utility, and clarity which elements of AOT programs Dated: May 14, 2018. of the information to be collected; and influence health and social outcomes for Leslie Kux, (4) the use of automated collection people under AOT orders, as well as the daltland on DSKBBV9HB2PROD with NOTICES Associate Commissioner for Policy. techniques or other forms of information use of services, associated costs, and [FR Doc. 2018–10551 Filed 5–16–18; 8:45 am] technology to minimize the information patient and family satisfaction with the BILLING CODE 4164–01–P collection burden. AOT process. Title of the Collection: Evaluation of Need and Proposed Use of the the Assisted Outpatient Treatment Grant Information: Section 224(e) of PAMA Program for Individuals with Serious requires annual reports to Congress that Mental Illness. include evaluation of: Cost savings and VerDate Sep<11>2014 18:36 May 16, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\17MYN1.SGM 17MYN1

22986 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices public health outcomes such as of homelessness among patients; and help ASPE address the evaluation mortality, suicide, substance abuse, patient and family satisfaction with questions listed above and inform the hospitalization, and use of services; program participation. The data required reports to Congress. rates of incarceration by patients; rates collected under this submission will TOTAL ESTIMATED ANNUALIZED BURDEN HOURS TO RESPONDENTS Average Number of Total annual Number of burden per Forms Respondents responses per burden respondents response respondent (hours) (hours) Client Interview Instrument ............... Program Participant ......................... 520 3 1.00 1560.00 Comparison Subjects ....................... 520 3 1.00 1560.00 Family Satisfaction Survey ............... Program Participant’s Family Mem- 173 1 15/60 43.25 ber. Cost Questionnaire ........................... Program Administrator ..................... 6 1 1.25 7.50 Other Site Representatives .............. 12 1 1.25 15.00 Docket Case Monitoring Form .......... AOT Local Evaluator ........................ 6 390 6/60 234.00 AOT Characteristics Form ................ AOT Local Evaluator ........................ 6 12 30/60 36.00 Total ........................................... ........................................................... 1,243 411 0.76 3,455.75 Terry Clark, ADDRESSES: You may submit either Staff, FDA will post your comment, as Office of the Secretary, Paperwork Reduction electronic or written comments on well as any attachments, except for Act Reports Clearance Officer. Agency guidances at any time as information submitted, marked and [FR Doc. 2018–10512 Filed 5–16–18; 8:45 am] follows: identified, as confidential, if submitted BILLING CODE 4150–05–P as detailed in ‘‘Instructions.’’ Electronic Submissions Instructions: All submissions received Submit electronic comments in the must include the Docket No. FDA– DEPARTMENT OF HEALTH AND following way: 2016–D–1605 for ‘‘Institutional Review HUMAN SERVICES • Federal eRulemaking Portal: Board (IRB) Written Procedures: https://www.regulations.gov. Follow the Guidance for Institutions and IRBs.’’ [Docket No. FDA–2016–D–1605] instructions for submitting comments. Received comments will be placed in Comments submitted electronically, the docket and, except for those Institutional Review Board Written including attachments, to https:// Procedures: Guidance for Institutions submitted as ‘‘Confidential www.regulations.gov will be posted to Submissions,’’ publicly viewable at and Institutional Review Boards; the docket unchanged. Because your Availability https://www.regulations.gov or at the comment will be made public, you are Dockets Management Staff between 9 AGENCY: The Office for Human Research solely responsible for ensuring that your a.m. and 4 p.m., Monday through Protections, Office of the Assistant comment does not include any Friday. confidential information that you or a Secretary for Health, Office of the • Confidential Submissions—To Secretary, and the Food and Drug third party may not wish to be posted, submit a comment with confidential Administration, HHS. such as medical information, your or information that you do not wish to be anyone else’s Social Security number, or ACTION: Notice of availability. made publicly available, submit your confidential business information, such comments only as a written/paper SUMMARY: The Office for Human as a manufacturing process. Please note submission. You should submit two Research Protections (OHRP), Office of that if you include your name, contact copies total. One copy will include the the Assistant Secretary for Health, and information, or other information that information you claim to be confidential the Food and Drug Administration identifies you in the body of your with a heading or cover note that states (FDA) are announcing the availability of comments, that information will be posted on https://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS a guidance entitled ‘‘Institutional CONFIDENTIAL INFORMATION.’’ The Review Board (IRB) Written Procedures: • If you want to submit a comment with confidential information that you Agency will review this copy, including Guidance for Institutions and IRBs.’’ the claimed confidential information, in The guidance is intended for do not wish to be made available to the public, submit the comment as a its consideration of comments. The institutions and IRBs responsible for second copy, which will have the review and oversight of human subject written/paper submission and in the manner detailed (see ‘‘Written/Paper claimed confidential information research under the Department of redacted/blacked out, will be available Health and Human Services (HHS) and Submissions’’ and ‘‘Instructions’’). for public viewing and posted on FDA regulations. The purpose of this Written/Paper Submissions https://www.regulations.gov. Submit guidance is to assist staff at institutions Submit written/paper submissions as both copies to the Dockets Management and IRBs who are responsible for follows: Staff. If you do not wish your name and daltland on DSKBBV9HB2PROD with NOTICES preparing and maintaining written • Mail/Hand delivery/Courier (for contact information to be made publicly procedures. The guidance announced in written/paper submissions): Dockets available, you can provide this this notice finalizes the draft guidance Management Staff (HFA–305), Food and information on the cover sheet and not of the same title dated August 2016. Drug Administration, 5630 Fishers in the body of your comments and you DATES: The announcement of the Lane, Rm. 1061, Rockville, MD 20852. must identify this information as guidance is published in the Federal • For written/paper comments ‘‘confidential.’’ Any information marked Register on May 17, 2018. submitted to the Dockets Management as ‘‘confidential’’ will not be disclosed VerDate Sep<11>2014 18:36 May 16, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\17MYN1.SGM 17MYN1


Document Created: 2018-05-17 00:50:40
Document Modified: 2018-05-17 00:50:40
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.
DatesComments on the ICR must be received on or before June 18, 2018.
ContactSherrette Funn, [email protected] or (202) 795-7714. When submitting comments or requesting information, please include the document identifier 0990-New-30D and project title for reference.
FR Citation83 FR 22985 
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