Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal, 27009-27010 [2018-12440]
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
27009
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section/activity
Total annual
disclosures
Average
burden per
disclosure
Total hours
558.6(b)(3)–(b)(5) and (b)(7)–(b)(9); required disclosures when a veterinarian issues a VFD.
558.6(c)(8); required disclosure (acknowledgement
letter) from one distributor to another.
3,050
246
750,000
0.125 (7 minutes) ......
93,750
1,000
5
5,000
0.125 (7 minutes) ......
625
Total ..................................................................
........................
........................
........................
....................................
94,375
daltland on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The VFD regulation also contains
several labeling provisions that are
exempt from OMB review and approval
under the PRA because they are a
‘‘public disclosure of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)) and therefore do not
constitute a ‘‘collection of information’’
under the PRA (44 U.S.C. 3501, et seq.).
All labeling and advertising for VFD
drugs, combination VFD drugs, and
feeds containing VFD drugs or
combination VFD drugs must
prominently and conspicuously display
the following cautionary statement:
‘‘Caution: Federal law restricts
medicated feed containing this
veterinary feed directive (VFD) drug to
use by or on the order of a licensed
veterinarian’’ (§ 558.6(a)(6)). In addition,
the veterinarian must ensure that the
following statement is included on the
VFD (§ 558.6(b)(3)(xiii)): ‘‘Use of feed
containing this veterinary feed directive
(VFD) drug in a manner other than as
directed on the labeling (extralabel use)
is not permitted.’’
The veterinarian may restrict VFD
authorization to only include the VFD
drug(s) cited on the VFD or such
authorization may be expanded to allow
the use of the cited VFD drug(s) along
with one or more over-the-counter
animal drugs in an approved,
conditionally approved, or indexed
combination VFD drug (§ 558.6(b)(6)).
The veterinarian must affirm his or her
intent regarding combination VFD drugs
by including one of the following
statements on the VFD:
1. ‘‘This VFD only authorizes the use
of the VFD drug(s) cited in this order
and is not intended to authorize the use
of such drug(s) in combination with any
other animal drugs’’ (§ 558.6(b)(6)(i)).
2. ‘‘This VFD authorizes the use of the
VFD drug(s) cited in this order in the
following FDA-approved, conditionally
approved, or indexed combination(s) in
medicated feed that contains the VFD
drug(s) as a component.’’ (List specific
approved, conditionally approved, or
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19:19 Jun 08, 2018
Jkt 244001
indexed combination medicated feeds
following this statement.)
(§ 558.6(b)(6)(ii)).
3. ‘‘This VFD authorizes the use of the
VFD drug(s) cited in this order in any
FDA-approved, conditionally approved,
or indexed combination(s) in medicated
feed that contains the VFD drug(s) as a
component’’ (§ 558.6(b)(6)(iii)).
These labeling statements are not
subject to review by OMB because, as
stated previously, they are a ‘‘public
disclosure of information originally
supplied by the Federal government to
the recipient for the purpose of
disclosure to the public’’ (5 CFR
1320.3(c)(2)) and therefore do not
constitute a ‘‘collection of information’’
under the PRA (44 U.S.C. 3501, et seq.).
The one-time burdens included in
FDA’s analysis of the June 3, 2015, final
rule (80 FR 31708 at 31729 to 31732) are
not included in the estimate provided in
this notice. FDA’s estimate of the annual
recurring burden for this information
collection has not changed since the last
OMB approval.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12448 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1768]
Advisory Committee; Pharmacy
Compounding 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 Pharmacy Compounding
Advisory Committee by the
Commissioner of Food and Drugs (the
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Pharmacy
Compounding Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 25, 2020.
DATES: Authority for the Pharmacy
Compounding Advisory Committee will
expire on April 25, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Chee, 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,
PCAC@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
Pharmacy Compounding Advisory
Committee (the Committee). The
committee is a non-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 compounding drugs for human
use and, as required, any other product
for which FDA has regulatory
responsibility.
The Committee shall provide advice
on scientific, technical, and medical
issues concerning drug compounding
under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a and 353b), and, as
required, any other product for which
FDA has regulatory responsibility, and
make appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 12 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
E:\FR\FM\11JNN1.SGM
11JNN1
27010
Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. 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
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
members who are 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/
PharmacyCompounding
AdvisoryCommittee/ucm381305.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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12440 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2018–N–1725]
Advisory Committee; Peripheral and
Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Peripheral and Central
Nervous System 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
Peripheral and Central Nervous System
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until June 4, 2020.
DATES: Authority for the Peripheral and
Central Nervous System Drugs Advisory
Committee will expire on June 4, 2020,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Yinghua Wang, 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, email: PCNS@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
Peripheral and Central Nervous System
Drugs Advisory Committee. The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Peripheral and Central Nervous
System 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
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 neurologic
diseases.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, 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
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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/
PeripheralandCentralNervousSystem
DrugsAdvisoryCommittee/default.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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12443 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–0327]
Determination That MUTAMYCIN
(Mitomycin) Injectable, 5 Milligrams/
Vial and 20 Milligrams/Vial, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that MUTAMYCIN
(mitomycin) injectable, 5 milligrams
(mg)/vial and 20 mg/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
SUMMARY:
E:\FR\FM\11JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27009-27010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12440]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1768]
Advisory Committee; Pharmacy Compounding 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 Pharmacy Compounding 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 Pharmacy
Compounding Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until April
25, 2020.
DATES: Authority for the Pharmacy Compounding Advisory Committee will
expire on April 25, 2020, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Cindy Chee, 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,
[email protected].
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 Pharmacy Compounding Advisory Committee (the Committee).
The committee is a non-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 compounding drugs for human use and,
as required, any other product for which FDA has regulatory
responsibility.
The Committee shall provide advice on scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b),
and, as required, any other product for which FDA has regulatory
responsibility, and make appropriate recommendations to the
Commissioner.
The Committee shall consist of a core of 12 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of
[[Page 27010]]
pharmaceutical compounding, pharmaceutical manufacturing, pharmacy,
medicine, and related specialties. These members will include
representatives from the National Association of Boards of Pharmacy,
the United States Pharmacopeia, pharmacists with current experience and
expertise in compounding, physicians with background and knowledge in
compounding, and patient and public health advocacy organizations.
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 or more technically qualified members, selected by the Commissioner
or designee, who are identified with consumer interests and are
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one or more non-voting members who are 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/PharmacyCompoundingAdvisoryCommittee/ucm381305.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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12440 Filed 6-8-18; 8:45 am]
BILLING CODE 4164-01-P
