Document ID: FDA-2012-N-0454-0002
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: 2012-07-26T04:00Z

[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43841-43842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18233]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0454]

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.

DATES: Fax written comments on the collection of information by August 
27, 2012.

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 0910-0640. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, juanmanuel.vilela@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 0910-0640)--Extension

    On December 22, 2006, the President signed into law the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 
109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) with respect to serious adverse event 
reporting for dietary supplements and nonprescription drugs marketed 
without an approved application.
    Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added 
by Public Law 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 responsible person 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. Separate guidance, 
issued by the Center for Food Safety and Applied Nutrition on reporting 
for dietary supplements, is announced elsewhere in the Federal 
Register.
    Title: 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.

[[Page 43842]]

    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.
    Burden Estimate: FDA is requesting public comment on the estimated 
one-time reporting burden from these respondents, as required by 502(x) 
of the FD&C Act and described in the guidance ``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.'' The estimates for 
one-time reporting are based on FDA's knowledge of nonprescription drug 
product labeling in the United States, whether or not marketed under an 
approved application.
    In the Federal Register of May 15, 2012 (77 FR 28604), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1--Estimated One-Time Reporting Burden \1\
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                                                                                         Number of
                                                                        Number of      responses per   Total responses   Average burden    Total hours
                                                                       respondents       respondent                       per response
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Domestic address or phone number labeling requirement (21 U.S.C.                200              500          100,000                4          400,000
 502(x)) and recommendation to clarify its purpose.................
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\1\ There are no capital costs or maintenance and operating costs associated with this collection of information.

    As indicated in table 1 of this document, FDA estimates that 
approximately 200 manufacturers will revise approximately 100,000 
labels to add a full domestic address and 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. FDA believes 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. This estimate accounts for the 
possibility that every manufacturer will make label revision, which is 
unlikely. Because the majority of over-the-counter drug product labels 
currently have a domestic telephone number that satisfies the 
requirement, we believe many manufacturers will opt not to adopt the 
guidance's recommendation to add a statement identifying the purpose of 
the address or telephone number, significantly reducing the number of 
total responses. However, assuming that all labels are revised, we 
estimate a one-time reporting burden for this information collection of 
400,000 hours.

    Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18233 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P