Psychopharmacologic Drugs Advisory Committee; Cancellation, 43608 [2019-18026]
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43608
Federal Register / Vol. 84, No. 162 / Wednesday, August 21, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part 60—
Patent Term Restoration
Number of
responses
per
respondent
Number of
respondents
Total
responses
(2016–2018)
Average
burden per
response
Average
annual
burden
hours
60.24; revision of regulatory review period determinations ...............................
60.30; due diligence petitions ..................
60.40; due diligence hearings ..................
12
1
1
1.333
1
1
16
3
1
100
50
10
1,600
150
10
533.33
50
3.3
Total ..................................................
........................
........................
........................
........................
........................
586.63
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects a small
increase (+7 responses) associated with
submissions received under § 60.24 in
previous years.
Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17999 Filed 8–20–19; 8:45 am]
BILLING CODE 4164–01–P
Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18026 Filed 8–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0902]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2396]
Psychopharmacologic Drugs Advisory
Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Psychopharmacologic Drugs Advisory
Committee scheduled for July 31, 2019,
has been canceled. This meeting was
announced in the Federal Register of
June 14, 2019. This meeting has been
canceled because of new information
regarding the application. The Agency
intends to continue evaluating the
application and, as needed, will
announce future meeting dates in the
Federal Register.
FOR FURTHER INFORMATION CONTACT: Jay
Fajiculay, 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, Fax:
301–847–8533, email: PDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting,
which was announced in the Federal
Register of June 14, 2019 (84 FR 27783).
VerDate Sep<11>2014
18:13 Aug 20, 2019
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
AGENCY:
Food and Drug Administration,
HHS.
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
(PRA).
SUMMARY:
SUMMARY:
jspears on DSK3GMQ082PROD with NOTICES
Total hours
(2016–2018)
Jkt 247001
Fax written comments on the
collection of information by September
20, 2019.
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,
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 0910–0393. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
20852, 301–796–5733, 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:
Prescription Drug Product Labeling;
Medication Guide Requirements
OMB Control Number 0910–0393—
Extension
FDA regulations require the
distribution of patient labeling, called
Medication Guides, for certain
prescription human drug and biological
products used primarily on an
outpatient basis that pose a serious and
significant public health concern.
Medication Guides provide patients the
most important information about drug
products, including the drugs’ approved
uses, contraindications, adverse drug
reactions, and cautions for specific
populations. These regulations are
intended to improve the public health
by providing information necessary for
patients to use certain medications
safely and effectively.
The regulations contain the following
reporting requirements that are subject
to the PRA:
• § 208.20 (21 CFR 208.20)—
Applicants must submit draft
Medication Guides for FDA approval
according to the prescribed content and
format.
• §§ 314.70(b)(3)(ii) and 601.12(f) (21
CFR 314.70(b)(3)(ii) and 21 CFR
601.12(f))—Application holders must
submit changes to Medication Guides as
supplements to their applications to
FDA for approval.
• § 208.24(c) (21 CFR 208.24(c))—
Each distributor or packer who receives
Medication Guides, or the means to
produce Medication Guides, from a
manufacturer under paragraph (b) of
this section shall provide those
Medication Guides to each authorized
dispenser to whom it ships a drug
product.
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Page 43608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2396]
Psychopharmacologic Drugs Advisory Committee; Cancellation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The meeting of the Psychopharmacologic Drugs Advisory
Committee scheduled for July 31, 2019, has been canceled. This meeting
was announced in the Federal Register of June 14, 2019. This meeting
has been canceled because of new information regarding the application.
The Agency intends to continue evaluating the application and, as
needed, will announce future meeting dates in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, 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, Fax: 301-847-8533, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting, which was announced in the Federal
Register of June 14, 2019 (84 FR 27783).
Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18026 Filed 8-20-19; 8:45 am]
BILLING CODE 4164-01-P
