Agency Information Collection Request. 30-Day Public Comment Request, 22985-22986 [2018-10512]
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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
technologies as our resources permit.
FDA notes section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
381) also provides that FDA may charge
a fee of up to $175 if the Agency issues
a certificate within 20 days of receipt of
a complete request for such a certificate.
This fee may vary depending on the
22985
product type, but it will not exceed
$175.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average burden per
response
(in hours)
Total annual
responses
Type of respondent
FDA Form No.2
Cosmetics .....................
Food .............................
3613d ..........................
3613e, 3613g, 3613l ...
270
881
3
5
810
4,405
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
405
2,203
Total ......................
.....................................
........................
........................
........................
.....................................
2,608
Total hours
1 There
2 All
are no capital costs or operating and maintenance costs associated with this collection of information.
forms are submitted electronically via CAP.
daltland on DSKBBV9HB2PROD with NOTICES
This estimate reflects a revision
resulting from the elimination of paperbased forms. Specifically, and based on
our experience with the information
collection, we have reduced the
estimated time to prepare a submission
from 1.5 hours to 0.5 hour. The previous
estimate was based on the time
necessary to prepare a paper
submission, but all firms requesting
export certificates now provide
submissions electronically via CAP. We
believe that the time to prepare an
electronic submission is under 0.25
hour, but are estimating 0.5 hour as a
conservative approach to address all
scenarios. We base our estimates of the
total annual responses on our
experience with certificate applications
received in the past 3 fiscal years.
We expect that most firms requesting
export certificates in the next 3 years
will choose to take advantage of the
option of electronic submission via
CAP. If a firm is unable to submit their
information via CAP, they may contact
CFSAN and request assistance. CFSAN
will assist firms in entering their
information into the electronic system
so that the firm may receive their export
certificates in a timely manner. Our
burden estimates in table 1 are based on
the expectation of 100 percent
participation in the electronic
submission process. Providing the
opportunity to submit the information
in electronic format has reduced our
previous estimates for the time to
prepare each submission.
Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10551 Filed 5–16–18; 8:45 am]
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Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 4year 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
E:\FR\FM\17MYN1.SGM
17MYN1
22986
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
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
respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
Total annual
burden
(hours)
Forms
Respondents
Client Interview Instrument ...............
520
520
173
3
3
1
1.00
1.00
15/60
1560.00
1560.00
43.25
Docket Case Monitoring Form ..........
AOT Characteristics Form ................
Program Participant .........................
Comparison Subjects .......................
Program Participant’s Family Member.
Program Administrator .....................
Other Site Representatives ..............
AOT Local Evaluator ........................
AOT Local Evaluator ........................
6
12
6
6
1
1
390
12
1.25
1.25
6/60
30/60
7.50
15.00
234.00
36.00
Total ...........................................
...........................................................
1,243
411
0.76
3,455.75
Family Satisfaction Survey ...............
Cost Questionnaire ...........................
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2018–10512 Filed 5–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–D–1605]
Institutional Review Board Written
Procedures: Guidance for Institutions
and Institutional Review Boards;
Availability
The Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, and the Food and Drug
Administration, HHS.
ACTION: Notice of availability.
AGENCY:
The Office for Human
Research Protections (OHRP), Office of
the Assistant Secretary for Health, and
the Food and Drug Administration
(FDA) are announcing the availability of
a guidance entitled ‘‘Institutional
Review Board (IRB) Written Procedures:
Guidance for Institutions and IRBs.’’
The guidance is intended for
institutions and IRBs responsible for
review and oversight of human subject
research under the Department of
Health and Human Services (HHS) and
FDA regulations. The purpose of this
guidance is to assist staff at institutions
and IRBs who are responsible for
preparing and maintaining written
procedures. The guidance announced in
this notice finalizes the draft guidance
of the same title dated August 2016.
DATES: The announcement of the
guidance is published in the Federal
Register on May 17, 2018.
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SUMMARY:
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18:36 May 16, 2018
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You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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–
2016–D–1605 for ‘‘Institutional Review
Board (IRB) Written Procedures:
Guidance for Institutions and IRBs.’’
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 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
E:\FR\FM\17MYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22985-22986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10512]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
