Document ID: FDA-2007-D-0429-0027
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Posted Date: 2016-02-19T05:00Z

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8507-8508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03457]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429 (formerly Docket No. 2007D-0496)]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Questions and Answers Regarding the 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 (the PRA).

DATES: Fax written comments on the collection of information by March 
21, 2016.

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 title. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Guidance for Industry on Questions and Answers Regarding the 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)), which was 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 contains questions and answers relating to this labeling 
requirement and provides guidance to industry on the following topics: 
(1) The meaning of ``domestic address'' for purposes of the labeling 
requirements of section 502(x) of the FD&C Act; (2) 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 (3) 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 
(issued in 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.
    In the Federal Register of July 17, 2015 (80 FR 42502), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. However, these 
comments did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 8508]]

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \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 (21 U.S.C. 502(x))...................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03457 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P