Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements, 43608-43609 [2019-18000]
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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
43609
Federal Register / Vol. 84, No. 162 / Wednesday, August 21, 2019 / Notices
• § 208.24(e) (21 CFR 208.24(e))—
Each authorized dispenser of a
prescription drug product for which a
Medication Guide is required must
provide a Medication Guide directly to
each patient when dispensing the
product to the patient or to the patient’s
agent, unless an exemption applies
under § 208.26 (21 CFR 208.26).
• § 208.26(a)—Requests may be
submitted for an exemption or a deferral
from particular Medication Guide
content or format requirements.
In the Federal Register of October 26,
2018 (83 FR 54110), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
encouraging the use of ‘‘provider-
neutral language’’ in places where terms
such as ‘‘doctor’’ or ‘‘physician’’ are
used suggesting that these terms may
cause some confusion for patients. We
are appreciative of this
recommendation; however, we decline
to implement such changes.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Content and Format of a Medication Guide—§ 208.20 .......
Supplements and Other Changes to an Approved Application—§§ 314.70(b)(3)(ii) and 601.12(f) .............................
Exemptions and Deferrals—§ 208.26(a) ..............................
61
1
61
320
19,520
155
1
1
1
155
1
72
4
11,160
4
Total ..............................................................................
........................
........................
........................
........................
30,684
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Total annual
disclosures
Average burden
per disclosure
Total hours
Distributing Medication Guide to Authorized Dispenser—§ 208.24(c) .............................................
Distributing and Dispensing a Medication Guide to
Patient—§ 208.24(e) .............................................
191
9,000
1,719,000
1.25
2,148,750
88,736
5,705
506,238,880
0.05 (3 minutes)
25,311,944
Total ..................................................................
........................
........................
............................
............................
27,460,694
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated annual reporting
burden for the information collection
reflects an overall increase of 4,664 total
hours. We attribute this adjustment to
an increase in the number of
submissions we received over the last
few years. Based on a review of the
information collection since our last
request for OMB approval, we have
made no adjustments to our annual
third-party disclosure burden estimate.
Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18000 Filed 8–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jspears on DSK3GMQ082PROD with NOTICES
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section
[Document Identifier: OS–0990–0221]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
VerDate Sep<11>2014
18:13 Aug 20, 2019
Jkt 247001
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before October 21, 2019.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D,
and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Family
Planning Annual Report (FPAR).
Type of Collection: Renewal with
change.
OMB No.: 0990–0221.
Abstract: The Office of Population
Affairs within the Office of the Assistant
Secretary for Health is requesting an
extension on a currently approved
Family Planning Annual Report (FPAR)
data collection and reporting tool (OMB
No. 0990–0221). This annual reporting
requirement is for family planning
services delivery projects authorized
and funded by the Title X Family
Planning Program [‘‘Population
Research and Voluntary Family
Planning Programs’’ (Public Law 91–
572)], which was enacted in 1970 as
Title X of the Public Health Service Act
(Section 1001; 42 U.S.C. 300). The FPAR
data collection and reporting tool will
include a new module to collect
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Pages 43608-43609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0902]
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.
-----------------------------------------------------------------------
SUMMARY: 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).
DATES: 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 [email protected]. 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.
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 20852, 301-796-5733,
[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.
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:
Sec. 208.20 (21 CFR 208.20)--Applicants must submit draft
Medication Guides for FDA approval according to the prescribed content
and format.
Sec. Sec. 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.
Sec. 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.
[[Page 43609]]
Sec. 208.24(e) (21 CFR 208.24(e))--Each authorized
dispenser of a prescription drug product for which a Medication Guide
is required must provide a Medication Guide directly to each patient
when dispensing the product to the patient or to the patient's agent,
unless an exemption applies under Sec. 208.26 (21 CFR 208.26).
Sec. 208.26(a)--Requests may be submitted for an
exemption or a deferral from particular Medication Guide content or
format requirements.
In the Federal Register of October 26, 2018 (83 FR 54110), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received encouraging the use
of ``provider-neutral language'' in places where terms such as
``doctor'' or ``physician'' are used suggesting that these terms may
cause some confusion for patients. We are appreciative of this
recommendation; however, we decline to implement such changes.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Content and Format of a 61 1 61 320 19,520
Medication Guide--Sec. 208.20
Supplements and Other Changes to 155 1 155 72 11,160
an Approved Application--Sec.
Sec. 314.70(b)(3)(ii) and
601.12(f)......................
Exemptions and Deferrals--Sec. 1 1 1 4 4
208.26(a)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 30,684
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Distributing Medication Guide to Authorized Dispenser--Sec. 191 9,000 1,719,000 1.25 2,148,750
208.24(c)........................................................
Distributing and Dispensing a Medication Guide to Patient--Sec. 88,736 5,705 506,238,880 0.05 (3 minutes) 25,311,944
208.24(e)........................................................
-------------------------------------------------------------------------------------
Total......................................................... .............. .............. ................ ................ 27,460,694
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated annual reporting burden for the information
collection reflects an overall increase of 4,664 total hours. We
attribute this adjustment to an increase in the number of submissions
we received over the last few years. Based on a review of the
information collection since our last request for OMB approval, we have
made no adjustments to our annual third-party disclosure burden
estimate.
Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18000 Filed 8-20-19; 8:45 am]
BILLING CODE 4164-01-P
