Eleventh Meeting of the National Clinical Care Commission; Correction, 26534 [2021-10258]
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26534
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
21 CFR section/activity
Total ......................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
................................
Total hours
88,370
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
indexed combination medicated feeds
following this statement.)
(§ 558.6(b)(6)(ii)).
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
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.).
Based on a review of the information
collection since our last request for
OMB approval, there has been a
significant increase in the number of
VFD distributors due to changes to the
VFD regulations that were implemented
in 2017. Since implementation, the
number of approved VFD drugs has
increased. As a result, the burden for the
information collection has increased
69,148 hours since the last OMB
approval.
Since the publication of the 60-day
notice, we have adjusted 7 minutes for
the average burden per response from
0.125 to 0.117. We believe this is a
better representation for 7 minutes. As
a result, this has slightly changed the
burden hours.
Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10245 Filed 5–13–21; 8:45 am]
May 4, 2021, concerning a virtual
meeting of the National Clinical Care
Commission. The date of the eleventh
meeting of the Commission has
changed. The original dates for the
eleventh meeting were May 19 and June
1, 2021. The new dates for the two-day
meeting are June 1 and June 22, 2021.
Kara
Elam, Ph.D., MPH, MS, Designated
Federal Officer, National Clinical Care
Commission, U.S. Department of Health
and Human Services, Office on
Women’s Health, 200 Independence
Ave. SW, 7th Floor, Washington, DC
20201, Phone: (240) 435–9438, Email:
Kara.Elam@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of May 4,
2021, FR Doc. 2021–09277, page 23731,
in the first column, correct the SUMMARY
caption to read:
The National Clinical Care
Commission (the Commission) will
conduct its eleventh meeting virtually
on June 1 and June 22, 2021. The
Commission is charged to evaluate and
make recommendations to the U.S.
Department of Health and Human
Services (HHS) Secretary and Congress
regarding improvements to the
coordination and leveraging of federal
programs related to diabetes and its
complications.
SUMMARY:
BILLING CODE 4164–01–P
Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the Federal Register of May 4,
2021, FR Doc. 2021–09277, page 23731,
in the first column, correct the DATES
caption to read:
Eleventh Meeting of the National
Clinical Care Commission; Correction
DATES:
Office on Women’s Health,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice; correction.
AGENCY:
The Office of the Assistant
Secretary for Health published a
document in the Federal Register of
SUMMARY:
PO 00000
Frm 00078
Fmt 4703
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The two-day meeting will take
place June 1 and June 22, 2021 from 1
p.m. to approximately 6 p.m. Eastern
Time (ET).
Dated: May 4, 2021.
Dorothy A. Fink,
Deputy Assistant Secretary for Women’s
Health.
[FR Doc. 2021–10258 Filed 5–13–21; 8:45 am]
BILLING CODE 4150–32–P
E:\FR\FM\14MYN1.SGM
14MYN1
Agencies
[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Page 26534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Eleventh Meeting of the National Clinical Care Commission;
Correction
AGENCY: Office on Women's Health, Office of the Assistant Secretary for
Health, Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Health published a
document in the Federal Register of May 4, 2021, concerning a virtual
meeting of the National Clinical Care Commission. The date of the
eleventh meeting of the Commission has changed. The original dates for
the eleventh meeting were May 19 and June 1, 2021. The new dates for
the two-day meeting are June 1 and June 22, 2021.
FOR FURTHER INFORMATION CONTACT: Kara Elam, Ph.D., MPH, MS, Designated
Federal Officer, National Clinical Care Commission, U.S. Department of
Health and Human Services, Office on Women's Health, 200 Independence
Ave. SW, 7th Floor, Washington, DC 20201, Phone: (240) 435-9438, Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of May 4, 2021, FR Doc. 2021-09277, page
23731, in the first column, correct the Summary caption to read:
SUMMARY: The National Clinical Care Commission (the Commission) will
conduct its eleventh meeting virtually on June 1 and June 22, 2021. The
Commission is charged to evaluate and make recommendations to the U.S.
Department of Health and Human Services (HHS) Secretary and Congress
regarding improvements to the coordination and leveraging of federal
programs related to diabetes and its complications.
Correction
In the Federal Register of May 4, 2021, FR Doc. 2021-09277, page
23731, in the first column, correct the Dates caption to read:
DATES: The two-day meeting will take place June 1 and June 22, 2021
from 1 p.m. to approximately 6 p.m. Eastern Time (ET).
Dated: May 4, 2021.
Dorothy A. Fink,
Deputy Assistant Secretary for Women's Health.
[FR Doc. 2021-10258 Filed 5-13-21; 8:45 am]
BILLING CODE 4150-32-P