[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Notices]
[Page 196-197]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-62]
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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Draft Guidance for Industry on Questions and Answers Regarding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availability of a draft guidance entitled ``Questions and Answers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 This draft guidance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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance,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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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