[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3192-3194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429]


Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on certain labeling statements for 
nonprescription human drug products marketed without an approved 
application.

DATES: Submit either electronic or written comments on the collection 
of information by April 12, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 12, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2007-D-0429 for ``Labeling of Nonprescription Human Drug Products 
Marketed Without an Approved Application as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management

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Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. For a copy of guidance documents, go to 
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm; insert 
the title of the guidance document in the ``Search'' box and follow 
prompts.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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.
    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\
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                                                                                         Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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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).....
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\1\ There are no capital costs or maintenance and operating costs associated with this collection of information.


[[Page 3194]]

    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: February 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01793 Filed 2-8-19; 8:45 am]
 BILLING CODE 4164-01-P