
[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]               
[Page 8264-8265]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe09-81]                         

-----------------------------------------------------------------------

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; 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

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 (the PRA). Elsewhere in this issue of 
the Federal Register, FDA is announcing that a proposed collection of 
information regarding dietary supplement labeling requirements and 
recommendations has been submitted for OMB review.

DATES: Fax written comments on the collection of information by March 
26, 2009.

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the title ``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.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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: Questions and Answers

    On December 22, 2006, the President signed into law the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Public Law 
109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and 
Cosmetic Act (the act) with respect to serious adverse event reporting 
for dietary supplements and nonprescription drugs marketed without an 
approved application.
    Section 502(x) of the 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. In the Federal Register of January 
2, 2008 (73 FR 196), FDA announced the availability of a draft guidance 
document entitled ``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.'' In the Federal Register of December 11, 
2008 (73 FR 75436), FDA published a notice of availability of a revised 
version of the same draft guidance document. The guidance document 
contains questions and answers relating to the 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 act; (2) FDA's recommendation for the use of an 
introductory statement before the domestic address or telephone number 
that is required to appear on the product label under section 502(x) of 
the act; and (3) FDA's intent regarding enforcing the labeling 
requirements of section 502(x) of the act.
    Title: 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.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors whose name 
(under section 502(b)(1) of the act (21 U.S.C. 352(b)(1))) 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 act and described in the guidance ``Labeling of Nonprescription 
Human Drug Products Marketed Without an Approved Application as 
Required by

[[Page 8265]]

the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act: Questions and Answers.'' 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                      No. of           Frequency per                            Hours per
                   Respondents           Response         Total Responses        Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Domestic                      200                   500            100,000                  4            400,000
 address or
 telephone
 number
 labeling
 requirement
 (21 U.S.C.
 502(x)) and
 recommendatio
 n to clarify
 its purpose
----------------------------------------------------------------------------------------------------------------
\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, we estimate 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, 
estimate a one-time reporting burden for this information collection of 
400,000 hours.
    In the Federal Register of January 2, 2008 (73 FR 196), FDA 
published a notice of availability for the original draft guidance that 
also gave notice of the proposed collections of information in the 
draft guidance, included an analysis and burden estimate for those 
proposed collections of information, and provided 60 days for public 
comment under the PRA. FDA did not revise the PRA burden analysis and 
estimate when it issued the revised draft guidance in December 2008 
because the revisions did not affect them.
    FDA received one comment on the proposed collections of 
information, stating that the time involved in revising labels would be 
significantly longer than the typical timeframe to implement labeling 
changes because the volume of labels required to be revised at one time 
might exceed manufacturers' labeling revision capacity. Several 
comments requested that FDA extend the date of its enforcement 
discretion. In response to comments, in December 2008, FDA published a 
notice of availability of the revised draft guidance for industry. The 
revised draft guidance was identical to the first draft guidance, with 
the exception that, in the revised draft guidance, FDA stated its 
intention to exercise enforcement discretion until January 1, 2010. As 
a result, any label revision made as a result of this guidance would 
likely be made contemporaneously with other scheduled label revisions, 
minimizing the burden to industry.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3917 Filed 2-23-09; 8:45 am]

BILLING CODE 4160-01-S
