[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]


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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.

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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 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.

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\
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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 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


