Agency Information Collection Request. 60-Day Public Comment Request, 14643-14644 [2018-06959]
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Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 this 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. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard T. Lostritto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4132,
Silver Spring, MD 20993–0002, 301–
796–1697.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Liposome Drug Products: Chemistry,
Manufacturing, and Controls; Human
Pharmacokinetics and Bioavailability;
and Labeling Documentation.’’ This
guidance provides recommendations to
applicants on the CMC, human
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pharmacokinetics and bioavailability,
and labeling documentation for
liposome drug products submitted in
NDAs and ANDAs reviewed by CDER.
Although this guidance does not intend
to provide recommendations specific to
liposome drug products to be marketed
under biologics license applications
(BLAs), many scientific principles
described in this guidance may also
apply to these products.
In the Federal Register of August 21,
2002 (67 FR 54220), FDA announced the
availability of a draft version of this
guidance. FDA published a revised draft
guidance on October 30, 2015 (80 FR
66906), because of the need to address
changes in technology since the draft
was first published in 2002, and to add
ANDAs to the scope. Most of the
changes to the 2015 revised draft
guidance were made to clarify
statements in the 2002 draft guidance.
FDA received comments in response to
the draft and revised draft guidance, and
this guidance reflects FDA’s careful
consideration of those comments.
The guidance does not provide
recommendations on clinical efficacy
and safety studies, nonclinical
pharmacology and/or toxicology
studies, liposome formulations of
vaccine adjuvants or biologics, or druglipid complexes.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Liposome Drug
Products: Chemistry, Manufacturing,
and Controls; Human Pharmacokinetics
and Bioavailability; and Labeling
Documentation.’’ 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. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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14643
Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06926 Filed 4–4–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0438]
Agency Information Collection
Request. 60-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 4, 2018.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0438–60D
and project title for reference, to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer.
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: Teen
Pregnancy Prevention Performance
Measures Data Collection, Office of
Adolescent Health.
Type of Collection: Revision.
OMB No.: 0990–0438.
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS) is
requesting approval by OMB on a
revision of the Teen Pregnancy
Prevention (TPP) Performance Measures
from funded grantees. The performance
measures data include grantee-level
measures (dissemination, partners,
SUMMARY:
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Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices
training, sustainability), and programlevel data (reach, dosage, fidelity and
quality). The data collection will
provide OAH with the data needed to
comply with accountability and federal
performance requirements for the 1993
Government Performance and Results
Act (Pub. L. 103–62); it will inform
stakeholders of progress in meeting the
goals of the program and of
sustainability efforts; it will provide
OAH with metrics for monitoring TPP
grantees and it will facilitate grantees’
continuous quality improvement in
program implementation. Clearance is
requested for three years.
The likely respondents would be the
estimated 85 TPP grantees. TPP grantees
will report all of the data to OAH twice
per year.
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Respondents
(if necessary)
Grantee-level measures ....................
Program-level Measures ...................
TPP grantees ...................................
TPP grantees ...................................
85
85
2
2
1
372/60
170
1054
Total ...........................................
...........................................................
........................
4
........................
1224
Dated: March 30, 2018.
Terry S. Clark,
Asst. Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
[FR Doc. 2018–06959 Filed 4–4–18; 8:45 am]
BILLING CODE 4168–11–P
Notice of Meeting for the
Interdepartmental Serious Mental
Illness Coordinating Committee
(ISMICC)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
National Institutes of Health
National Library of Medicine;
Amended; Notice of Meeting
Notice is hereby given of a change in
the meeting of the Board of Regents of
the National Library of Medicine, May
8, 2018, 9:00 a.m. to May 9, 2018, 12:00
p.m., National Library of Medicine,
Building 38, 2nd Floor, The Donald A.B.
Lindberg Room, 8600 Rockville Pike,
Bethesda, MD, 20892 which was
published in the Federal Register on
March 7, 2018, 83 FR 45 Page 9746.
The meeting will be open to the
public on May 9, 2018 from 9:00 a.m.
to 10:30 a.m. and will then be closed
from 10:30 a.m. to 12:00 p.m., to review
intramural programs and projects. The
meeting is partially closed to the public.
Dated: March 30, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–06898 Filed 4–4–18; 8:45 am]
BILLING CODE 4140–01–P
The Secretary of Health and
Human Services (Secretary), in
accordance with section 6031 of the 21st
Century Cures Act, announces a meeting
of the Interdepartmental Serious Mental
Illness Coordinating Committee
(ISMICC).
The meeting is open to the public and
will include information on federal
efforts related to serious mental illness
(SMI) and serious emotional disturbance
(SED), including data evaluation, and
recommendations for action. Committee
members will also discuss ISMICC
member relationship to implementation
workgroups, establishing the prevalence
of SMI and SED, communication with
non-federal organizations to engage nonfederal support for ISMICC, and future
meetings.
Committee Name: Interdepartmental
Serious Mental Illness Coordinating
Committee.
SUMMARY:
June 8, 2018/9:00 a.m.–5:00
p.m. (EDT).
ADDRESSES: The meeting will be held at
the Hubert H. Humphrey Building, 200
Independence Avenue SW, Room 800,
Washington, DC 20201.
The meeting can be accessed via
webcast at www.hhs.gov/live, or by
joining the teleconference at toll-free
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DATE/TIME:
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Total burden
hours
number 1–888–928–9713, passcode
7160920.
The public comment section is
scheduled for 1:00 p.m. Eastern Daylight
Time (EDT), and individuals interested
in submitting a comment, must notify
the Designated Federal Official (DFO),
Ms. Pamela Foote, on or before May 24,
2018 via email to: Pamela.Foote@
samhsa.hhs.gov.
Two minutes will be allotted for each
approved public comment as time
permits. Written comments received in
advance of the meeting will be included
in the official record of the meeting.
Substantive meeting information and
a roster of Committee members is
available at the Committee’s website
https://www.samhsa.gov/about-us/
advisory-councils/smi-committee.
SUPPLEMENTARY INFORMATION:
I. Background and Authority
The ISMICC was established on
March 15, 2017, in accordance with
section 6031 of the 21st Century Cures
Act, and the Federal Advisory
Committee Act, 5 U.S.C. App., as
amended, to report to the Secretary,
Congress, and any other relevant federal
department or agency on advances in
serious mental illness (SMI) and serious
emotional disturbance (SED), research
related to the prevention of, diagnosis
of, intervention in, and treatment and
recovery of SMIs, SEDs, and advances in
access to services and support for adults
with SMI or children with SED. In
addition, the ISMICC will evaluate the
effect federal programs related to serious
mental illness have on public health,
including public health outcomes such
as (A) rates of suicide, suicide attempts,
incidence and prevalence of SMIs,
SEDs, and substance use disorders,
overdose, overdose deaths, emergency
hospitalizations, emergency room
boarding, preventable emergency room
visits, interaction with the criminal
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[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14643-14644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0438]
Agency Information Collection Request. 60-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 4, 2018.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0438-60D and
project title for reference, to [email protected], or call the
Reports Clearance Officer.
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: Teen Pregnancy Prevention Performance
Measures Data Collection, Office of Adolescent Health.
Type of Collection: Revision.
OMB No.: 0990-0438.
Abstract: The Office of Adolescent Health (OAH), U.S. Department of
Health and Human Services (HHS) is requesting approval by OMB on a
revision of the Teen Pregnancy Prevention (TPP) Performance Measures
from funded grantees. The performance measures data include grantee-
level measures (dissemination, partners,
[[Page 14644]]
training, sustainability), and program-level data (reach, dosage,
fidelity and quality). The data collection will provide OAH with the
data needed to comply with accountability and federal performance
requirements for the 1993 Government Performance and Results Act (Pub.
L. 103-62); it will inform stakeholders of progress in meeting the
goals of the program and of sustainability efforts; it will provide OAH
with metrics for monitoring TPP grantees and it will facilitate
grantees' continuous quality improvement in program implementation.
Clearance is requested for three years.
The likely respondents would be the estimated 85 TPP grantees. TPP
grantees will report all of the data to OAH twice per year.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms (if necessary) Respondents (if Number of responses per Average burden Total burden
necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
Grantee-level measures........ TPP grantees.... 85 2 1 170
Program-level Measures........ TPP grantees.... 85 2 372/60 1054
---------------------------------------------------------------------------------
Total..................... ................ .............. 4 .............. 1224
----------------------------------------------------------------------------------------------------------------
Dated: March 30, 2018.
Terry S. Clark,
Asst. Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2018-06959 Filed 4-4-18; 8:45 am]
BILLING CODE 4168-11-P
