Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 25061-25062 [2019-11295]
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25061
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices
concerning the withdrawal of LUPRON
(leuprolide acetate) injection, 1 mg/0.2
mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list LUPRON (leuprolide
acetate) injection, 1 mg/0.2 mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11243 Filed 5–29–19; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2007–D–0429]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act
Food and Drug Administration,
HHS.
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.
DATES: Fax written comments on the
collection of information by July 1,
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 0910–0641. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
SUMMARY:
Labeling of Nonprescription Human
Drug Products Marketed Without an
Approved Application as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
OMB Control Number 0910–0641—
Extension
Section 502(x) of the Federal, Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), added by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act (Pub. L. 109–
462), requires the label of a
nonprescription drug product marketed
without an approved application in the
United States to include a domestic
address or domestic telephone number
through which a manufacturer, packer,
and distributor may receive a report of
a serious adverse event associated with
the product. The guidance document
entitled ‘‘Labeling of Nonprescription
Human Drug Products Marketed
Without an Approved Application as
Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act: Questions and Answers’’
explains how FDA interprets this
requirement. The guidance discusses
the meaning of ‘‘domestic address’’ for
purposes of the labeling requirements of
section 502(x) of the FD&C Act, FDA’s
recommendation for the use of an
introductory statement before the
domestic address or phone number that
is required to appear on the product
label under section 502(x) of the FD&C
Act, and FDA’s intent regarding
enforcing the labeling requirements of
section 502(x) of the FD&C Act.
In the Federal Register of February
11, 2019 (84 FR 3192), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) of the FD&C Act)
appears on the label of a
nonprescription drug product marketed
in the United States without an
approved application.
As indicated in table 1 of this
document, we estimate that 300
manufacturers will revise approximately
900 labels to add a full domestic address
or a domestic telephone number, and
should they choose to adopt the
guidance’s recommendation, to add a
statement identifying the purpose of the
domestic address or telephone number.
We believe that designing the label
change should not take longer than 4
hours per label. Automated printing of
the labels should only require a few
seconds per label.
We estimate the burden of this
collection of information as follows:
jbell on DSK3GLQ082PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NEW OTC DRUG PRODUCTS 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Including a domestic address or phone number and a
statement of its purpose on OTC drug labeling (section
502(x) of the FD&C Act) ..................................................
300
3
900
4
3,600
1 There
are no capital costs or maintenance and operating costs associated with this collection of information.
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25062
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11295 Filed 5–29–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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:
Fax written comments on the
collection of information by July 1,
2019.
DATES:
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 0910–0731. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
jbell on DSK3GLQ082PROD with NOTICES
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:
VerDate Sep<11>2014
18:08 May 29, 2019
Jkt 247001
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products
OMB Control Number 0910–0731—
Extension
The Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31)
offers tobacco product manufacturers
several pathways to obtain an order
from FDA to authorize the marketing of
a new tobacco product before it may be
introduced or delivered into interstate
commerce. To provide assistance with
these pathways to market products, FDA
will meet with tobacco product
manufacturers, importers, researchers,
and investigators (or their
representatives) when appropriate as
described in Guidance on Meetings with
Industry and Investigators on the
Research and Development of Tobacco
Products. This guidance is intended to
assist persons who seek meetings with
FDA relating to their research to inform
the regulation of tobacco products, or to
support the development or marketing
of tobacco products. The original
guidance issued in 2012 was revised for
updating and clarity in July 2016.
In the guidance, the Agency
discusses, among other things:
• What information FDA
recommends persons include in a
meeting request;
• How and when to submit a request;
and
• What information FDA
recommends persons submit prior to a
meeting.
This guidance describes two
collections of information: (1) The
submission of a meeting request
containing certain information and (2)
the submission of an information
package in advance of the meeting. The
purpose of this proposed information
collection is to allow FDA to conduct
meetings with tobacco manufacturers,
importers, researchers, and investigators
in an effective and efficient manner.
FDA issued this guidance and the
revisions consistent with FDA’s good
guidance practices regulations (21 CFR
10.115).
Meeting Requests: The guidance sets
forth FDA’s recommendations for
materials to be included in a request for
a meeting with FDA to discuss the
research and development of tobacco
products. In the guidance, FDA
recommends that the following
information be included in the meeting
request:
1. Product name and FDA-assigned
Submission Tracking Number (if
applicable);
2. Product category (e.g., cigarettes,
smokeless tobacco) (if applicable);
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Fmt 4703
Sfmt 4703
3. Product use (indicate for consumer
use or for further manufacturing);
4. Contact information for the
authorized point of contact for the
company requesting the meeting;
5. The topic of the meeting being
requested (e.g., a new tobacco product
application, an application for
permission to market a modified risk
tobacco product, or investigational use
of a new tobacco product);
6. A brief statement of the purpose of
the meeting, which could include a
discussion of the types of studies or data
to be discussed at the meeting, the
general nature of the primary questions
to be asked, and where the meeting fits
in the overall product development
plans;
7. A preliminary list of the specific
objectives/outcomes expected from the
meeting;
8. A preliminary proposed agenda,
including an estimate of the time
needed and a designated speaker for
each agenda item;
9. A preliminary list of specific
questions, grouped by discipline (e.g.,
chemistry, clinical, nonclinical);
10. A list of all individuals who will
attend the meeting on behalf of the
tobacco product manufacturer, importer,
researcher, or investigator, including
titles and responsibilities;
11. The date on which the meeting
information package will be received by
FDA; and
12. Suggested format of the meeting
(e.g., conference call, in-person meeting
at FDA offices, video conference, or
written response) and suggested dates
and times for the meeting. Meetings are
usually scheduled for 1 hour.
This information will be used by the
Agency to: (1) Determine the utility of
the meeting, (2) identify Agency staff
necessary to discuss proposed agenda
items, and (3) schedule the meeting.
Meeting Information Packages: An
individual submitting a meeting
information package to FDA in advance
of a meeting should provide summary
information relevant to the product and
supplementary information pertaining
to any issue raised by the individual or
FDA to be discussed at the meeting. As
stated in the guidance, FDA
recommends that meeting information
packages generally include updates of
information that was submitted with the
meeting request and, as applicable:
1. Product composition and design
data summary;
2. Manufacturing and process control
data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data
summary;
E:\FR\FM\30MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25061-25062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0429]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act
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.
DATES: Fax written comments on the collection of information by July 1,
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 0910-0641.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act
OMB Control Number 0910-0641--Extension
Section 502(x) of the Federal, Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 352(x)), added by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Pub. L. 109-462),
requires the label of a nonprescription drug product marketed without
an approved application in the United States to include a domestic
address or domestic telephone number through which a manufacturer,
packer, and distributor may receive a report of a serious adverse event
associated with the product. The guidance document entitled ``Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers'' explains how FDA
interprets this requirement. The guidance discusses the meaning of
``domestic address'' for purposes of the labeling requirements of
section 502(x) of the FD&C Act, FDA's recommendation for the use of an
introductory statement before the domestic address or phone number that
is required to appear on the product label under section 502(x) of the
FD&C Act, and FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the FD&C Act.
In the Federal Register of February 11, 2019 (84 FR 3192), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(under section 502(b)(1) of the FD&C Act) appears on the label of a
nonprescription drug product marketed in the United States without an
approved application.
As indicated in table 1 of this document, we estimate that 300
manufacturers will revise approximately 900 labels to add a full
domestic address or a domestic telephone number, and should they choose
to adopt the guidance's recommendation, to add a statement identifying
the purpose of the domestic address or telephone number. We believe
that designing the label change should not take longer than 4 hours per
label. Automated printing of the labels should only require a few
seconds per label.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Including a domestic address or phone number and a statement of its 300 3 900 4 3,600
purpose on OTC drug labeling (section 502(x) of the FD&C Act).....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance and operating costs associated with this collection of information.
[[Page 25062]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11295 Filed 5-29-19; 8:45 am]
BILLING CODE 4164-01-P
