Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, Renewal, 29868-29869 [2016-11323]
Download as PDF
<![CDATA[
29868
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
ingredients or dietary supplements are
permissible under section 403(r)(6) of
the FD&C Act. Draft screenshots of Form
FDA 3955 and instructions are available
for comment at https://www.fda.gov/
Food/DietarySupplements/IndustryInfo/
ucm485532.htm.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
In the Federal Register of March 11,
2016 (81 FR 12910), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment in support of the information
collection.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
101.93 ......................................................................
1 There
Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–11272 Filed 5–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
mstockstill on DSK3G9T082PROD with NOTICES
2,200
Total annual
responses
1
2,200
Average burden per
response
0.75 (45 minutes) ......
Total hours
1,650
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal
burden on the industry to generate
information to meet the notification
requirements of section 403(r)(6) of the
FD&C Act by submitting information
regarding section 403(r)(6) of the FD&C
Act statements on labels or in labeling
of dietary supplements. We also believe
that submission via FURLS will not
affect the burden estimates. We are
requesting only information that is
immediately available to the
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
We estimate that, each year,
approximately 2,200 firms will submit
the information required by section
403(r)(6) of the FD&C Act. This estimate
is based on the average number of
notification submissions received by us
in the preceding 3 years. We estimate
that a firm will require 0.75 hours to
gather the information needed and
prepare a communication to us, for a
total of 1,650 hours (2,200 × 0.75).
Advisory Committee; PulmonaryAllergy Drugs Advisory Committee,
Renewal
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pulmonary-Allergy Drugs
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 Pulmonary-Allergy
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until May 30, 2018.
DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will
expire on May 30, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, 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,
PADAC@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
Pulmonary-Allergy Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The PulmonaryAllergy Drugs Advisory Committee
advises the Commissioner or designee
in discharging responsibilities 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 for
use in the treatment of pulmonary
disease and diseases with allergic and/
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
or immunologic mechanisms 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
pulmonary medicine, allergy, clinical
immunology, and epidemiology or
statistics. 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/
PulmonaryAllergyDrugsAdvisoryCommittee/
ucm107567.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.
E:\FR\FM\13MYN1.SGM
13MYN1
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
Dated: May 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11323 Filed 5–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0971]
Infectious Disease Next Generation
Sequencing Based Diagnostic
Devices: Microbial Identification and
Detection of Antimicrobial Resistance
and Virulence Markers; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Infectious Disease Next Generation
Sequencing Based Diagnostic Devices:
Microbial Identification and Detection
of Antimicrobial Resistance and
Virulence Markers.’’ This draft guidance
provides recommendations to assist
industry in designing studies to
establish the analytical and clinical
performance characteristics of infectious
disease next generation sequencingbased diagnostic devices for microbial
identification and detection of
antimicrobial resistance and virulence
markers. This draft guidance is neither
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 11,
2016.
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
mstockstill on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
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): 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–
2016–D–0971 for ‘‘Infectious Disease
Next Generation Sequencing Based
Diagnostic Devices: Microbial
Identification and Detection of
Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry;
Availability.’’ 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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
29869
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
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.
Submit written requests for single
copies of the guidance to the Office of
the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Heike Sichtig, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4526, Silver Spring,
MD 20993–0002, 301–796–4574.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides
recommendations to assist industry in
designing studies to establish the
analytical and clinical performance
characteristics of ‘‘Infectious Disease
Next Generation Sequencing Based
Diagnostic Devices’’ for microbial
identification and detection of
antimicrobial resistance and virulence
markers (hereinafter referred to as
‘‘Infectious Disease NGS Dx devices’’).
Infectious Disease NGS Dx devices are
intended for use as an aid in the
diagnosis of microbial infection and in
selecting appropriate therapies for
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29868-29869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Pulmonary-Allergy Drugs 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 Pulmonary-Allergy Drugs 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 Pulmonary-
Allergy Drugs Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until May
30, 2018.
DATES: Authority for the Pulmonary-Allergy Drugs Advisory Committee
will expire on May 30, 2016, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Cindy Hong, 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,
PADAC@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 Pulmonary-Allergy Drugs Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Pulmonary-Allergy Drugs
Advisory Committee advises the Commissioner or designee in discharging
responsibilities 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
for use in the treatment of pulmonary disease and diseases with
allergic and/or immunologic mechanisms 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 pulmonary medicine, allergy, clinical immunology, and
epidemiology or statistics. 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/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm107567.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.
[[Page 29869]]
Dated: May 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11323 Filed 5-12-16; 8:45 am]
BILLING CODE 4164-01-P
