Agency Information Collection Activities; Submission for Office of Management and Budget Review; Extralabel Drug Use in Animals, 1262-1263 [2018-00237]
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Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6827]
Advisory Committee; Vaccines and
Related Biological 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 Vaccines and Related
Biological 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
Vaccines and Related Biological
Products Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 31, 2019.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2019, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6338, Silver Spring, MD 20993–0002,
240–402–5771, serina.hunter-thomas@
fda.hhs.gov.
SUMMARY:
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
Vaccines and Related Biological
Products 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 vaccines and related biological
products for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
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SUPPLEMENTARY INFORMATION:
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other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of 15 voting members, including the
Chairperson (the Chair). Members and
the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of immunology, molecular biology,
rDNA, virology, bacteriology,
epidemiology or biostatistics, vaccine
policy, vaccine safety science, federal
immunization activities, vaccine
development including translational
and clinical evaluation programs,
allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and
biochemistry. 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. Ex
Officio voting members one each from
the Department of Health and Human
Services, the Centers for Disease Control
and Prevention, and the National
Institutes of Health may be included.
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 consumeroriented 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. There
may also be an alternate industry
representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
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that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at: https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Blood
VaccinesandOtherBiologics/
VaccinesandRelatedBiologicalProducts
AdvisoryCommittee/ucm129571.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 check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00239 Filed 1–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Extralabel Drug Use in Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February 9,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
SUMMARY:
E:\FR\FM\10JAN1.SGM
10JAN1
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0325. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Extralabel Drug Use in Animals—21
CFR Part 530
OMB Control Number 0910–0325—
Extension
The Animal Medicinal Drug Use
Clarification Act of 1994 (Pub. L. 103–
396) allows a veterinarian to prescribe
the extralabel use of approved new
animal drugs. Also, it permits FDA, if it
finds that there is a reasonable
probability that the extralabel use of an
animal drug may present a risk to the
public health, to establish a safe level
for a residue from the extralabel use of
the drug, and to require the
development of an analytical method for
the detection of residues above that
established safe level (21 CFR
530.22(b)). Although, to date, we have
not established a safe level for a residue
from the extralabel use of any new
animal drug and, therefore, have not
required the development of analytical
methodology, we believe that there may
1263
be instances when analytical
methodology will be required. We are,
therefore, estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal and/or State Agencies,
academia, or individuals.
In the Federal Register of June 26,
2017 (82 FR 28858), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
530.22(b), Submission(s) of Analytical Method ...................
2
1
2
4,160
8,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate has not changed,
and remains the same.
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2017–N–4951]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Humanitarian Use Devices
Food and Drug Administration,
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
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18:23 Jan 09, 2018
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0332. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
[FR Doc. 2018–00237 Filed 1–9–18; 8:45 am]
AGENCY:
Fax written comments on the
collection of information by February 9,
2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Fmt 4703
Sfmt 4703
Medical Devices; Humanitarian Use
Devices—21 CFR Part 814
OMB Control Number 0910–0332—
Extension
This collection of information
implements the humanitarian use
devices (HUDs) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360j(m)) and part 814, subpart H (21
CFR part 814, subpart H). Under section
520(m) of the FD&C Act, FDA is
authorized to exempt an HUD from the
effectiveness requirements of sections
514 and 515 of the FD&C Act (21 U.S.C.
360d and 360e) provided that the
device: (1) Is designed to treat or
diagnose a disease or condition that
affects no more than 8,000 individuals
in the United States; (2) would not be
available to a person with a disease or
condition unless an exemption is
granted and there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose such
disease or condition; and (3) will not
expose patients to an unreasonable or
significant risk of illness or injury and
the probable benefit to health from the
use of the device outweighs the risk of
injury or illness from its use, taking into
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]]>Agencies
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1262-1263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Extralabel Drug Use in Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 9, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs,
[[Page 1263]]
OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
[email protected]. All comments should be identified with the
OMB control number 0910-0325. Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Extralabel Drug Use in Animals--21 CFR Part 530
OMB Control Number 0910-0325--Extension
The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L.
103-396) allows a veterinarian to prescribe the extralabel use of
approved new animal drugs. Also, it permits FDA, if it finds that there
is a reasonable probability that the extralabel use of an animal drug
may present a risk to the public health, to establish a safe level for
a residue from the extralabel use of the drug, and to require the
development of an analytical method for the detection of residues above
that established safe level (21 CFR 530.22(b)). Although, to date, we
have not established a safe level for a residue from the extralabel use
of any new animal drug and, therefore, have not required the
development of analytical methodology, we believe that there may be
instances when analytical methodology will be required. We are,
therefore, estimating the reporting burden based on two methods being
required annually. The requirement to establish an analytical method
may be fulfilled by any interested person. We believe that the sponsor
of the drug will be willing to develop the method in most cases.
Alternatively, FDA, the sponsor, and perhaps a third party may
cooperatively arrange for method development. The respondents may be
sponsors of new animal drugs, State, or Federal and/or State Agencies,
academia, or individuals.
In the Federal Register of June 26, 2017 (82 FR 28858), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
530.22(b), Submission(s) of Analytical Method...................... 2 1 2 4,160 8,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate has not changed, and remains the same.
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00237 Filed 1-9-18; 8:45 am]
BILLING CODE 4164-01-P
