[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 196-197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D- 0496]


Draft Guidance for Industry on Questions and Answers Regarding 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; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Questions and Answers 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.'' This draft guidance 
is intended to assist industry in complying with the labeling 
requirements for nonprescription (over-the-counter (OTC)) human drugs 
marketed without an approved application established by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act. Separate 
guidance, issued by the Center for Food Safety and Applied Nutrition on 
labeling requirements for dietary supplements, is announced elsewhere 
in this issue of the Federal Register.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance, 
including comments regarding proposed collection of information, by 
March 3, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, addressStreet5630 Fishers Lane, rm. 1061, 
placeCityRockville, StateMD PostalCode20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Walter Ellenberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5488, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance 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.'' 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. The draft guidance document contains questions 
and answers relating to the new labeling requirements under Public Law 
109-462 for OTC drugs marketed without an approved application.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirement of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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 as follows.
    With respect to the following collection of information, FDA 
invites comment on the following: (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 on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Labeling Requirements and Recommendations under the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act for 
Nonprescription Drug Products Marketed Without an Approved Application.

[[Page 197]]

    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors whose name 
(under section 502(b)(1) of the act) appears on the label of a 
nonprescription drug marketed in the United States.
    Burden Estimate: FDA is requesting public comment on the estimated 
one-time reporting burden from these respondents, as required by Public 
Law 109-462 and described in the draft guidance. This guidance document 
discusses the labeling requirements of section 502(x) of the act (21 
U.S.C. 352(x)), which was added by Public Law 109-462.
    Section 502(x) of the act requires the label of an OTC drug product 
marketed without an approved application in the United States to 
include a domestic address or domestic phone number through which the 
responsible person may receive a report of a serious adverse event 
associated with the product. If the label does not include the required 
domestic address or phone number, the drug product is misbranded. When 
the responsible person chooses to provide a domestic address (rather 
than a phone number) for adverse event reporting, FDA concludes that 
the statute requires the product label to bear a full U.S. mailing 
address that includes the street address or P.O. Box, city, state, and 
zip code of the responsible person (i.e., the manufacturer, packer, 
distributor, or retailer whose name appears on the label). This 
labeling requirement helps to ensure that any mailed adverse event 
report will reach the responsible person. Similarly, when the 
responsible person chooses to provide a domestic phone number for 
adverse event reporting, FDA concludes that the statute requires the 
phone number on the product label to include the area code. Without the 
area code, the phone number is incomplete and does not serve its 
intended purpose of enabling the consumer to contact the responsible 
person to report a serious adverse event.
    In addition to discussing the statutory requirement that labels 
include a domestic address or a domestic phone number, the draft 
guidance includes recommendations about the location of this 
information on the label and the recommendation that the label make 
clear the purpose of this information.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1.--Estimated One-Time Reporting Burden\1\
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                                         No. of      Frequency  per       Total         Hours Per
                                       Respondents      Response        Responses       Response     Total Hours
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Domestic address or phone number                200             500         100,000               4      400,000
 labeling requirement (21 U.S.C.
 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, we estimate that 
approximately 200 manufacturers will revise approximately 100,000 
labels total to add a full domestic address and a domestic telephone 
number, and should they choose to adopt the draft guidance's 
recommendation, to add a statement identifying the purpose of the 
domestic address or telephone number. We specifically request comments 
on these estimates. 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.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance, including comments regarding proposed collection of 
information. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The draft guidance and 
received comments are available for public examination in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-6267 Filed 12-27-07; 3:08 pm]
BILLING CODE 4160-01-S