Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal, 28084-28085 [2016-10766]
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28084
Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2015–N–4602 for ‘‘Streamlining
Regulations for Good Manufacturing
Practices for Hearing Aids; Public
Workshop; Request for Comments.’’
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
Division of Dockets Management
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 Division of Dockets
Management. 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
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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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Srinivas Nandkumar, Food and Drug
Administration, Center for Devices and
Radiological Health, Bldg. 66, Rm. 2436,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–6480, FAX:
301–847–8126, Srinivas.nandkumar@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 7, 2016 (81
FR 784), FDA published a document
with a 30-day comment period to
request comments on the appropriate
level of GMPs regulation to ensure the
safety and effectiveness of airconduction hearing aid devices; the
current regulations for air-conduction
hearing aids that may hinder
innovation, reduce competition, and
lead to increased cost and reduced use
of these devices by Americans with agerelated hearing loss; and the potential
exemption of hearing aids from the
Quality System Regulation (QSReg,)
through use of alternative standards
developed in collaboration with key
stakeholders and standards
development organizations, and
recognized by FDA and recordkeeping
to ensure product quality. Comments on
the ‘‘Streamlining Regulations for Good
Manufacturing Practices for Hearing
Aids’’ will inform the Agency on an
alternative model for quality
verification.
The Agency has received requests for
a 30-day extension of the comment
period for the document. Each request
conveyed concern that the current 30day comment period does not allow
sufficient time to develop a meaningful
or thoughtful response to the document
on ‘‘Streamlining Regulations for Good
Manufacturing Practices for Hearing
Aids.’’
FDA has considered the requests and
is extending the comment period for the
document on ‘‘Streamlining Regulations
for Good Manufacturing Practices for
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Hearing Aids’’ for 30 days, until June
30, 2016. The Agency believes that a 30day extension allows adequate time for
interested persons to submit comments
without significantly delaying
regulation on these important issues.
Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–10798 Filed 5–6–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Anesthetic and
Analgesic Drug Products Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Anesthetic and Analgesic
Drug Products Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Anesthetic and
Analgesic Drug Products Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until May
1, 2018.
DATES: Authority for the Anesthetic and
Analgesic Drug Products Advisory
Committee will expire on May 1, 2016,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, AADPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Issued in
41 CFR 102–3.65 and approval by the
Department of Health and Human
Services issued in 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Anesthetic and Analgesic Drug Products
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Anesthetic
and Analgesic Drug Products Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
SUMMARY:
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Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility. The
Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products
including analgesics, e.g., abusedeterrent opioids, novel analgesics, and
issues related to opioid abuse, and those
for use in anesthesiology and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
anesthesiology, analgesics (such as:
abuse deterrent opioids, novel
analgesics, and issues related to opioid
abuse) epidemiology or statistics, and
related specialties. Members will be
invited to serve for overlapping terms of
up to four years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://www.
fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
AnestheticAndAnalgesicDrugProducts
AdvisoryCommittee/ucm094127.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). Since no change has been
made to the committee name or
description of duties, no amendment
will be made to 21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: May 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–10766 Filed 5–6–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OMB # 0990–0424–
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Assistant
Secretary for Health, Office of
Adolescent Health, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting that ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before July 8, 2016.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier OMB # 0990–0424–
60D for reference.
Information Collection Request Title:
Positive Adolescent Futures (PAF)
SUMMARY:
28085
Study Abstract: The Office of
Adolescent Health (OAH), U.S.
Department of Health and Human
Services (HHS) is requesting approval
by OMB on a revised data collection.
The Positive Adolescent Futures (PAF)
Study will provide information about
program design, implementation, and
impacts through a rigorous assessment
of program impacts and implementation
of two programs designed to support
expectant and parenting teens. These
programs are located in Houston, Texas
and throughout the state of California.
This revised information collection
request includes the 24-month followup survey instrument related to the
impact study. The data collected from
this instrument in the two study sites
will provide a detailed understanding of
program impacts about two years after
youth are enrolled in the study and first
have access to the programming offered
by each site.
Need and Proposed Use of the
Information: The data will serve two
main purposes. First, the data will be
used to determine program effectiveness
by comparing outcomes on repeat
pregnancies, sexual risk behaviors,
health and well-being, and parenting
behaviors between treatment (program)
and control youth. Second, the data will
be used to understand whether the
programs are more effective for some
youth than others. The findings from
these analyses of program impacts will
be of interest to the general public, to
policymakers, and to organizations
interested in supporting expectant and
parenting teens.
Likely Respondents: The 24-month
follow-up survey data will be collected
through a web-based survey or through
telephone interviews with study
participants; i.e. adolescents randomly
assigned to a program for expectant and
parenting teens being tested for program
effectiveness, or to a control group. The
mode of survey administration will
primarily be based on the preference of
the study participants. The survey will
be completed by 1,515 respondents
across the two study sites. Clearance is
requested for three years.
mstockstill on DSK3G9T082PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
24-month follow-up survey of impact study participants .................................
Total ..........................................................................................................
505
........................
1
........................
30/60
........................
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09MYN1
Total burden
hours
252.5
252.5
]]>Agencies
[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28084-28085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Anesthetic and Analgesic Drug Products
Advisory Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Anesthetic and Analgesic Drug Products Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Anesthetic and Analgesic Drug Products Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until May 1, 2018.
DATES: Authority for the Anesthetic and Analgesic Drug Products
Advisory Committee will expire on May 1, 2016, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (301)
796-9001, AADPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Issued in 41 CFR 102-3.65 and approval by
the Department of Health and Human Services issued in 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Anesthetic and Analgesic Drug Products Advisory
Committee. The committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner. The Anesthetic and
Analgesic Drug Products Advisory Committee advises the Commissioner or
designee in discharging responsibilities
[[Page 28085]]
as they relate to helping to ensure safe and effective drugs for human
use and, as required, any other product for which the Food and Drug
Administration has regulatory responsibility. The Committee reviews and
evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products including analgesics,
e.g., abuse-deterrent opioids, novel analgesics, and issues related to
opioid abuse, and those for use in anesthesiology and makes appropriate
recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of anesthesiology, analgesics (such as: abuse deterrent opioids,
novel analgesics, and issues related to opioid abuse) epidemiology or
statistics, and related specialties. Members will be invited to serve
for overlapping terms of up to four years. Almost all non-Federal
members of this committee serve as Special Government Employees. The
core of voting members may include one technically qualified member,
selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one non-
voting member who is identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm094127.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). Since no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: May 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-10766 Filed 5-6-16; 8:45 am]
BILLING CODE 4164-01-P
