Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 30875-30876 [2017-13890]
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Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
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SUPPLEMENTARY INFORMATION:
Agenda: The committees will discuss
new drug application (NDA) 209653, for
oxycodone hydrochloride extendedrelease oral tablets, submitted by
Intellipharmaceutics Corp., with the
proposed indication of management of
moderate-to-severe pain when a
continuous around-the-clock analgesic
is needed for an extended period of
time. The product has been formulated
with properties intended to deter abuse,
and the applicant has submitted data to
support these abuse-deterrent properties
for this product. The committees will be
asked to discuss the overall risk-benefit
profile of the product, and whether the
applicant has demonstrated abusedeterrent properties for their product
that would support labeling.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On July 26, 2017, from
9:15 a.m. to 5 p.m., the meeting is open
to the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. All electronic
and written submissions submitted to
the docket (see ADDRESSES) on or before
July 12, 2017, will be provided to the
committees. Oral presentations from the
public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 3, 2017. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 5, 2017.
Closed Committee Deliberations: On
July 26, 2017, from 8 a.m. to 9:15 a.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
During this session, the committees will
discuss the drug development program
of an investigational abuse-deterrent
opioid product.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Stephanie L.
Begansky at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13887 Filed 6–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–N–2976; FDA–
2016–N–3535; FDA–2013–N–1089; FDA–
2013–N–1619; FDA–2013–N–0719; FDA–
2016–N–3586; FDA–2013–N–0796; FDA–
2016–N–0736; FDA–2016–N–3995; FDA–
2013–D–0575; FDA–2016–N–0735]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, (301)
796–7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUMMARY:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
sradovich on DSK3GMQ082PROD with NOTICES
Title of collection
Request for Information From U.S. Processors That Export to the European Community ...................................
Guidance for Industry: Special Protocol Assessment .............................................................................................
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use ..........
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements ........................................................................................................................................................
Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products ..........................................................................................................................................
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Date
approval
expires
0910–0320
0910–0470
0910–0553
5/31/2020
5/31/2020
5/31/2020
0910–0606
5/31/2020
0910–0675
5/31/2020
30876
Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB
control No.
Title of collection
Focus Groups About Drug Products as Used by the Food and Drug Administration ............................................
Testing Communication on Medical Devices and Radiation-Emitting Products .....................................................
Tracking Network for PETNet, LivestockNet, and SampleNet ................................................................................
Medical Devices: Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure
Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics ..................................
Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs ........................................................
Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13890 Filed 6–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
notice is hereby given that the
Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
will hold a meeting that will be open to
the public. Information about SACHRP
and the full meeting agenda will be
posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
DATES: The meeting will be held on
Tuesday, July 25, 2017, from 8:30 a.m.
until 5:00 p.m., and Wednesday, July
26, 2017, from 8:30 a.m. until 2:30 p.m.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP, U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
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SUMMARY:
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issues and topics pertaining to or
associated with the protection of human
research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will open to the
public at 8:30 a.m., on Tuesday, July 25,
2017, followed by opening remarks from
Dr. Jerry Menikoff, Director, Office for
Human Research Protections and Dr.
Stephen Rosenfeld, SACHRP Chair.
(https://www.gpo.gov/fdsys/pkg/FR2017-01-19/html/2017-01058.htm).
The SOH will present their
recommendations regarding the new
Common Rule’s compliance dates and
transition provisions, as well as for the
interpretation and implementation of
the broad consent provision, followed
by the SAS discussing their report on
the interpretation of the new exemption
involving benign behavioral
interventions. The Tuesday, July 25,
meeting will adjourn at approximately
5:00 p.m.
The Wednesday, July 26, meeting will
begin at 8:30 a.m. with discussion of
recommendations from the SAS
regarding the new Common Rule’s
expedited review requirements.
The meeting will adjourn at
approximately 2:30 p.m., July 26, 2017.
Time for public comment sessions will
be allotted both days. On-site
registration is required for participation
in the live public comment session.
Note that public comment must be
relevant to issues currently being
addressed by the SACHRP. Individuals
submitting written statements as public
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approval
expires
0910–0677
0910–0678
0910–0680
5/31/2020
5/31/2020
5/31/2020
0910–0748
0910–0765
0910–0831
5/31/2020
5/31/2020
5/31/2020
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting.
Dated: June 27, 2017.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2017–13932 Filed 6–30–17; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Stakeholder Listening Session
on Strategies for Improving Parity for
Mental Health and Substance Use
Disorder Coverage
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a
public stakeholder listening session on
Strategies for Improving Parity for
Mental Health and Substance Use
Disorder Coverage. The public meeting,
mandated in the 21st Century Cures Act,
seeks public comment on improved
Federal and State coordination related
to section 2726 of the Public Health
Service Act, section 712 of the
Employee Retirement Income Security
Act of 1974, section 9812 of the Internal
Revenue Code of 1986, and any
comparable provisions of State law. The
public meeting will seek participation
from the required stakeholders in
statute, State health commissioners,
State agencies, State attorneys general,
the National Association of Insurance
Commissioners, health insurance
issuers, providers of mental health and
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Pages 30875-30876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2016-N-2976; FDA-2016-N-3535; FDA-2013-N-1089; FDA-
2013-N-1619; FDA-2013-N-0719; FDA-2016-N-3586; FDA-2013-N-0796; FDA-
2016-N-0736; FDA-2016-N-3995; FDA-2013-D-0575; FDA-2016-N-0735]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, (301) 796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Request for Information From U.S. 0910-0320 5/31/2020
Processors That Export to the European
Community..............................
Guidance for Industry: Special Protocol 0910-0470 5/31/2020
Assessment.............................
Use of Symbols on Labels and in Labeling 0910-0553 5/31/2020
of In Vitro Diagnostic Devices Intended
for Professional Use...................
Current Good Manufacturing Practice in 0910-0606 5/31/2020
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements............................
Guidance for Industry: Planning for the 0910-0675 5/31/2020
Effects of High Absenteeism to Ensure
Availability of Medically Necessary
Drug Products..........................
[[Page 30876]]
Focus Groups About Drug Products as Used 0910-0677 5/31/2020
by the Food and Drug Administration....
Testing Communication on Medical Devices 0910-0678 5/31/2020
and Radiation-Emitting Products........
Tracking Network for PETNet, 0910-0680 5/31/2020
LivestockNet, and SampleNet............
Medical Devices: Pediatric Uses of 0910-0748 5/31/2020
Devices; Requirements for Submission of
Information on Pediatric Subpopulations
That Suffer From a Disease or Condition
That a Device is Intended to Treat,
Diagnose, or Cure......................
Guidance for Industry: Expedited 0910-0765 5/31/2020
Programs for Serious Conditions--Drugs
and Biologics..........................
Superimposed Text in Direct-to-Consumer 0910-0831 5/31/2020
Promotion of Prescription Drugs........
------------------------------------------------------------------------
Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13890 Filed 6-30-17; 8:45 am]
BILLING CODE 4164-01-P
