Advisory Committee; Arthritis Advisory Committee, Renewal, 18860-18861 [2016-07362]
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18860
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
statistical analyses of clinical study
results.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Total
operating and
maintenance
costs
CLIA waiver application ...........................
40
1
40
1,200
48,000
$350,000
1 There
are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
CLIA waiver records ............................................................
40
1
40
2,800
112,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The total number of reporting and
recordkeeping hours is 160,000 hours.
FDA bases the burden on an Agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
1,200 hours per waiver application for
a total of 48,000 hours for reporting.
Based on previous years’ experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
maintaining the record for a total of
112,000 hours.
The total operating and maintenance
cost associated with the waiver
application is estimated at $350,000.
This cost is largely attributed to clinical
study costs incurred, which include site
selection and qualification, protocol
review, and study execution (initiation,
monitoring, closeout, and clinical site/
subject compensation—including
specimen collection for study as well as
shipping and supplies).
Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07365 Filed 3–31–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Arthritis
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 Arthritis 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
Arthritis Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 5, 2018.
DATES: Authority for the Arthritis
Advisory Committee will expire on
April 5, 2018, 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, AAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
SUMMARY:
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FDA is announcing the renewal of the
Arthritis Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The 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
FDA has regulatory responsibility. The
Committee reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases, and makes appropriate
recommendations to the Commissioner.
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 arthritis,
rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 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
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Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
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/
ArthritisAdvisoryCommittee/
ucm094137.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that 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: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07362 Filed 3–31–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the standardized format and content
requirements for the labeling of overthe-counter (OTC) drug products.
DATES: Submit either electronic or
written comments on the collection of
information by May 31, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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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
[Docket No. FDA–2013–N–0823]
AGENCY:
Electronic 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–
2013–N–0823 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Format
and Content Requirements for Over-theCounter Drug Product Labeling.’’
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
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18861
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
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
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]]>Agencies
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18860-18861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07362]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Arthritis 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 Arthritis 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 Arthritis Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until April 5, 2018.
DATES: Authority for the Arthritis Advisory Committee will expire on
April 5, 2018, 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, AAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Arthritis Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The 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 FDA has regulatory
responsibility. The Committee reviews and evaluates data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of arthritis, rheumatism, and related
diseases, and makes appropriate recommendations to the Commissioner.
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 arthritis, rheumatology, orthopedics, epidemiology or
statistics, analgesics, and related specialties. Members will be
invited to serve for overlapping terms of up to 4 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
[[Page 18861]]
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/ArthritisAdvisoryCommittee/ucm094137.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that 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: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07362 Filed 3-31-16; 8:45 am]
BILLING CODE 4164-01-P
