Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability, 197-200 [07-6266]
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197
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices
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 onetime 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109–462 and described in the draft
guidance.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number, the draft guidance includes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 BURDEN1
No. of
Respondents
Domestic address or phone number labeling requirement (21
U.S.C. 502(x)) and recommendation to clarify its purpose
1 There
200
Total
Responses
500
100,000
Hours Per
Response
Total Hours
4
400,000
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.
19:07 Dec 31, 2007
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2007D–0491]
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.
VerDate Aug<31>2005
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Food and Drug Administration
IV. Comments
pwalker on PROD1PC71 with NOTICES
Frequency
per Response
Jkt 214001
Draft Guidance for Industry: Questions
and Answers Regarding the Labeling
of Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Questions and Answers Regarding the
Labeling of Dietary Supplements as
Required by the Dietary Supplement
and Nonprescription Drug Consumer
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Protection Act.’’ This draft guidance is
intended to assist the dietary
supplement industry in complying with
the labeling requirements prescribed for
dietary supplement manufacturers,
packers, and distributors by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act (the
DSNDCPA). Separate guidance, issued
by the Center for Drug Evaluation and
Research on labeling requirements for
nonprescription (over-the-counter)
human drugs marketed without an
approved application, is announced
elsewhere in this issue of the Federal
Register.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by March 3, 2008.
DATES:
Submit written requests for
single copies of the draft guidance to the
Office of Nutritional Products, Labeling,
and Dietary Supplements (HFS–800),
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740. Send one self-addressed
adhesive label to assist the office in
processing your request, or include a fax
number to which the draft guidance
may be sent. See the SUPPLEMENTARY
ADDRESSES:
E:\FR\FM\02JAN1.SGM
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198
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices
INFORMATION section for electronic
access to the draft guidance.
Submit written comments on the draft
guidance, including comments
regarding proposed collection of
information, to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Vasilios Frankos, Center for Food Safety
and Applied Nutrition (HFS–810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2375.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Guidance for
Industry: Questions and Answers
Regarding the Labeling of Dietary
Supplements as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.’’ On
December 22, 2006, the President signed
into law the DSNDCPA (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 for dietary supplements
under the DSNDCPA.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’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. 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 in this document.
With respect to the following
collection of information, FDA invites
comment on these topics: (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: Dietary Supplement Labeling
Requirements and Recommendations
under the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors of dietary supplements
marketed in the United States.
The draft guidance is intended to
assist the dietary supplement industry
in complying with the dietary
supplement labeling requirements of
section 403(y) of the act (21 U.S.C.
343(y)), which was added by the
DSNDCPA.
Section 403(y) of the act requires the
label of a dietary supplement being
marketed in the United States to include
a domestic address or domestic
telephone number through which the
responsible person may receive a report
of a serious adverse event with such
dietary supplement. If the label does not
include the required domestic address
or telephone number, the dietary
supplement is misbranded. When the
responsible person chooses to provide a
domestic address (rather than a
telephone 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 identified on the
dietary supplement 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 telephone number
for adverse event reporting, FDA
concludes that the statute requires the
telephone number on the product label
to include the area code. Without the
area code, the telephone 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 for dietary supplement
labels to include a domestic address or
a domestic telephone number, the draft
guidance recommends that the label
bear a clear, prominent statement
informing consumers that the domestic
address or telephone number is for
reporting serious adverse events
associated with use of the product.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
pwalker on PROD1PC71 with NOTICES
Domestic address or telephone
number labeling requirement
(21 U.S.C. 343(y))
1,460
15.4616
22,574
4
90,296
FDA recommendation for label
statement explaining purpose
of domestic address or telephone number
1,460
15.4616
22,574
4
90,296
VerDate Aug<31>2005
19:07 Dec 31, 2007
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E:\FR\FM\02JAN1.SGM
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Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices
199
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden Hours
pwalker on PROD1PC71 with NOTICES
1There
Total Hours
180,592
are no capital costs or operating and maintenance costs associated with this collection of information.
Using FDA’s Labeling Cost Model,
FDA estimates that there are 22,574
stockkeeping units (SKUs) for unique
dietary supplement pills and liquids for
which labels would have to bear the
complete domestic address or domestic
telephone number of the responsible
person for that supplement. This
estimate of the number of SKUs for
dietary supplements is an underestimate
of the total number of dietary
supplements on the market because
dietary supplements are marketed in a
variety of forms other than pills and
liquids. However, this is the most
comprehensive estimate available to
FDA. FDA requests comments on the
total number of SKUs for dietary
supplements that are marketed in the
United States.
In the economic impact analysis of
the Dietary Supplement Good
Manufacturing Practices final rule (the
GMP final rule) FDA estimated that
there were about 1,460 dietary
supplement manufacturers, repackagers, re-labelers, and holders of
dietary supplements (June 25, 2007; 72
FR 34752 at 34920). Assuming the
22,574 SKUs are split equally among the
firms, then each firm would be
responsible for updating about 15 SKUs.
The estimate of the number of
manufacturers, re-packagers, re-labelers,
and holders of dietary supplements
from the GMP final rule is FDA’s best
estimate of the number of firms that are
‘‘responsible persons’’ who must
comply with the new labeling
requirement added by the DSNDCPA;
however, it is not a precise estimate
because the number of dietary
supplement establishments covered by
the GMP final rule is likely to be larger
than the number of ‘‘responsible
persons,’’ where a ‘‘responsible person’’
is a dietary supplement manufacturer,
packer, or distributor whose name is
listed on the label of a dietary
supplement associated with a serious
adverse event (see section 761(b)(1) of
the act (21 U.S.C. 379aa–1(b)(1)). Thus,
FDA’s estimate for number of
respondents in table 1 of this document
may be over inclusive. FDA requests
comments on the number of firms that
would be subject to the labeling
requirements of the DSNDCPA.
FDA does not know how many of the
22,574 dietary supplement SKUs would
VerDate Aug<31>2005
19:07 Dec 31, 2007
Jkt 214001
have to undergo a label change to
include the complete domestic address
or domestic telephone number of the
responsible person as required by the
DSNDCPA. Based on the agency’s
experience with regulating dietary
supplements, FDA believes that some
dietary supplement labels (SKUs)
already have the full domestic address
or telephone number of the responsible
person printed on the label and thus
will not need to be redesigned to
comply with section 403(y) of the act.
The agency does not have any
information on which to base a
quantitative estimate of the number of
labels that already meet the
requirements of section 403(y) of the
act, however. Therefore, FDA is
assuming conservatively that all labels
will need to be redesigned.
Assuming further that redesigning a
dietary supplement label to add a
domestic address or telephone number
requires one color change, and no
analytical tests are performed on the
new label, then FDA believes that
designing the label change should not
take longer than 4 hours per label. This
time would be used to assess the current
layout of each label and choose the best
location for the domestic address or
telephone number. Automated printing
of the labels should only require a few
seconds per label.
In addition to changing their labels to
meet the statutory requirement for a
domestic address or a domestic
telephone number, dietary supplement
firms may also choose to adopt the draft
guidance’s recommendation that the
label bear a clear, prominent statement
informing consumers that the domestic
address or telephone number is for
reporting serious adverse events
associated with use of the product. In
the absence of any information about
how many firms are likely to add such
an explanatory statement to their dietary
supplement labels, FDA is assuming
conservatively that the explanatory
statement will be added to all dietary
supplement labels.
FDA estimates that the burden of
including the recommended
explanatory statement on the label will
be similar to the burden of adding the
full domestic address or telephone
number to the dietary supplement label.
We assume it will take 4 hours per label
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
to assess the current layout of each label
and choose the best location for the
explanatory statement. Again we
assume this label modification would
require one color change and that no
premarket testing of the label wording
would be performed. FDA requests
comments on how many dietary
supplement firms and products would
follow FDA’s recommendation to
include such an explanatory statement
on the product’s label. FDA also
requests comments on the burden
associated with placing this explanatory
statement on the dietary supplement
label.
The likely overestimate of the total
burden caused by FDA’s conservative
assumption that all dietary supplement
labels (SKUs) will be redesigned to add
a domestic address or telephone number
and to include an explanatory statement
for consumers is offset to some degree
by the underestimate of the number of
SKUs in the marketplace resulting from
FDA’s lack of information on the
number of SKUs for dietary
supplements that are sold in a nonliquid or non-pill form. FDA requests
comments on the burden estimates
presented in table 1 of this document.
The agency is especially interested in
comments that include information
about: (1) The number of dietary
supplements marketed in the United
States in all forms and (2) the number
or percentage of dietary supplements
marketed in the United States that will
not require a label change to comply
with the requirement that dietary
supplements bear a complete domestic
address or telephone number. The
agency would also welcome information
on whether dietary supplement firms
plan to add the recommended
explanatory statement to their product
labels.
III. 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
E:\FR\FM\02JAN1.SGM
02JAN1
200
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices
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.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.cfsan.fda.gov/guidance.html.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–6266 Filed 12–27–07; 3:08 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Opioid Treatment
Programs (OTPs) Mortality Reporting
Form—NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment (CSAT), has developed a
voluntary reporting form for Opioid
Treatment Programs (OTPs) to report
mortality data on patients who at the
time of death, were enrolled in the
Programs that were certified to operate
by SAMHSA.
Methadone is a Schedule II controlled
substance approved by the Food and
Drug Administration for the treatment of
opioid dependence and pain. Although
it has proven safe and effective, it must
be carefully administered and for that
reason, treatment of opioid dependence
with methadone is provided only
through specialized and Federally
regulated and accredited clinics, the
OTPs. Buprenorphine, a Schedule III
controlled ssubstance, is also used in
the treatment of opioid addiction by
OTPs and office-based physicians.
In recent years, methadone has been
associated with an increasing number of
deaths around the country.
Simultaneously, the use of methadone
for pain has increased significantly over
the last 5 to 10 years. While the Food
and Drug Administration (FDA)
maintains oversight of methadone for
use in pain, SAMHSA provides
oversight of methadone for use in opioid
addiction treatment. Currently, there is
no national database that tracks
mortality among patients receiving
methadone in OTPs and as a result, it
is not clear whether and to what extent
the increase in methadone-associated
deaths may be related to treatment in
OTPs. MedWatch, a voluntary reporting
system maintained by FDA, provides
information relevant to its role in its
more general oversight of medication
and device safety. A similar system is
needed within SAMHSA to gather
information directly relevant to the
agency’s mission of overseeing and
ensuring safe and effective treatment for
patients with opioid dependence.
In order to more accurately
understand potential methadoneassociated deaths at the OTP level, it is
necessary to examine all patient deaths,
including those related to
buprenorphine. Understanding the
actual cause of death of patients
enrolled in OTPs can be a challenging
task for many reasons, including
inconsistencies in methods of reporting
causes of deaths across different
localities and officials; patients’ use of
other drugs, including illicit, over-thecounter, and prescription products; and
other aspects of the patient’s physical
and mental condition. The standardized
terminology to be used for reporting in
the proposed system will contribute to
a more precise and relevant analysis of
individual cases and higher-level
trends. The data will be used by
SAMHSA to increase understanding of
the factors contributing to these deaths,
identify preventable causes of deaths,
and ultimately, take appropriate action
to minimize risk and help improve the
quality of care. Importantly, better data
will enable the agency to more
proactively manage the oversight of
treatment.
The information requested from OTPs
should be readily available to any OTP
that has met accreditation standards.
The OTP should not find any need to
otherwise analyze or synthesize new
data in order to complete this form.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Number of
facilities
(OTPs)
Form
pwalker on PROD1PC71 with NOTICES
SAMHSA OTP Mortality Report .......................................................................
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
VerDate Aug<31>2005
19:07 Dec 31, 2007
Jkt 214001
1,150
Written comments should be received
within 60 days of this notice.
PO 00000
Burden
responses
(hours)
Responses
per facility
2
Fmt 4703
Sfmt 4703
1,150
Dated: December 31, 2007.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. 07–6254 Filed 12–31–07; 8:45 am]
BILLING CODE 4162–20–M
Frm 00054
0.5
Annual
burden
(hours)
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]]>Agencies
[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 197-200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-6266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0491]
Draft Guidance for Industry: Questions and Answers Regarding the
Labeling of Dietary Supplements as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Questions and Answers
Regarding the Labeling of Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act.''
This draft guidance is intended to assist the dietary supplement
industry in complying with the labeling requirements prescribed for
dietary supplement manufacturers, packers, and distributors by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
(the DSNDCPA). Separate guidance, issued by the Center for Drug
Evaluation and Research on labeling requirements for nonprescription
(over-the-counter) human drugs marketed without an approved
application, 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 comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 3, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutritional Products, Labeling, and Dietary
Supplements (HFS-800), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send one self-addressed adhesive label
to assist the office in processing your request, or include a fax
number to which the draft guidance may be sent. See the SUPPLEMENTARY
[[Page 198]]
INFORMATION section for electronic access to the draft guidance.
Submit written comments on the draft guidance, including comments
regarding proposed collection of information, to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to either https://www.fda.gov/dockets/ecomments or https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Vasilios Frankos, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Questions and Answers Regarding the Labeling
of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.'' On December 22, 2006,
the President signed into law the DSNDCPA (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 non-prescription drugs marketed without an approved
application. The draft guidance document contains questions and answers
relating to the new labeling requirements for dietary supplements under
the DSNDCPA.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA'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. 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 in this document.
With respect to the following collection of information, FDA
invites comment on these topics: (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: Dietary Supplement Labeling Requirements and Recommendations
under the Dietary Supplement and Nonprescription Drug Consumer
Protection Act.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors of dietary
supplements marketed in the United States.
The draft guidance is intended to assist the dietary supplement
industry in complying with the dietary supplement labeling requirements
of section 403(y) of the act (21 U.S.C. 343(y)), which was added by the
DSNDCPA.
Section 403(y) of the act requires the label of a dietary
supplement being marketed in the United States to include a domestic
address or domestic telephone number through which the responsible
person may receive a report of a serious adverse event with such
dietary supplement. If the label does not include the required domestic
address or telephone number, the dietary supplement is misbranded. When
the responsible person chooses to provide a domestic address (rather
than a telephone 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 identified on the dietary supplement 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 telephone number for
adverse event reporting, FDA concludes that the statute requires the
telephone number on the product label to include the area code. Without
the area code, the telephone 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 for dietary
supplement labels to include a domestic address or a domestic telephone
number, the draft guidance recommends that the label bear a clear,
prominent statement informing consumers that the domestic address or
telephone number is for reporting serious adverse events associated
with use of the product.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
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Domestic address or telephone number labeling 1,460 15.4616 22,574 4 90,296
requirement (21 U.S.C. 343(y))
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FDA recommendation for label statement explaining 1,460 15.4616 22,574 4 90,296
purpose of domestic address or telephone number
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Total Burden Hours 180,592
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Using FDA's Labeling Cost Model, FDA estimates that there are
22,574 stockkeeping units (SKUs) for unique dietary supplement pills
and liquids for which labels would have to bear the complete domestic
address or domestic telephone number of the responsible person for that
supplement. This estimate of the number of SKUs for dietary supplements
is an underestimate of the total number of dietary supplements on the
market because dietary supplements are marketed in a variety of forms
other than pills and liquids. However, this is the most comprehensive
estimate available to FDA. FDA requests comments on the total number of
SKUs for dietary supplements that are marketed in the United States.
In the economic impact analysis of the Dietary Supplement Good
Manufacturing Practices final rule (the GMP final rule) FDA estimated
that there were about 1,460 dietary supplement manufacturers, re-
packagers, re-labelers, and holders of dietary supplements (June 25,
2007; 72 FR 34752 at 34920). Assuming the 22,574 SKUs are split equally
among the firms, then each firm would be responsible for updating about
15 SKUs. The estimate of the number of manufacturers, re-packagers, re-
labelers, and holders of dietary supplements from the GMP final rule is
FDA's best estimate of the number of firms that are ``responsible
persons'' who must comply with the new labeling requirement added by
the DSNDCPA; however, it is not a precise estimate because the number
of dietary supplement establishments covered by the GMP final rule is
likely to be larger than the number of ``responsible persons,'' where a
``responsible person'' is a dietary supplement manufacturer, packer, or
distributor whose name is listed on the label of a dietary supplement
associated with a serious adverse event (see section 761(b)(1) of the
act (21 U.S.C. 379aa-1(b)(1)). Thus, FDA's estimate for number of
respondents in table 1 of this document may be over inclusive. FDA
requests comments on the number of firms that would be subject to the
labeling requirements of the DSNDCPA.
FDA does not know how many of the 22,574 dietary supplement SKUs
would have to undergo a label change to include the complete domestic
address or domestic telephone number of the responsible person as
required by the DSNDCPA. Based on the agency's experience with
regulating dietary supplements, FDA believes that some dietary
supplement labels (SKUs) already have the full domestic address or
telephone number of the responsible person printed on the label and
thus will not need to be redesigned to comply with section 403(y) of
the act. The agency does not have any information on which to base a
quantitative estimate of the number of labels that already meet the
requirements of section 403(y) of the act, however. Therefore, FDA is
assuming conservatively that all labels will need to be redesigned.
Assuming further that redesigning a dietary supplement label to add
a domestic address or telephone number requires one color change, and
no analytical tests are performed on the new label, then FDA believes
that designing the label change should not take longer than 4 hours per
label. This time would be used to assess the current layout of each
label and choose the best location for the domestic address or
telephone number. Automated printing of the labels should only require
a few seconds per label.
In addition to changing their labels to meet the statutory
requirement for a domestic address or a domestic telephone number,
dietary supplement firms may also choose to adopt the draft guidance's
recommendation that the label bear a clear, prominent statement
informing consumers that the domestic address or telephone number is
for reporting serious adverse events associated with use of the
product. In the absence of any information about how many firms are
likely to add such an explanatory statement to their dietary supplement
labels, FDA is assuming conservatively that the explanatory statement
will be added to all dietary supplement labels.
FDA estimates that the burden of including the recommended
explanatory statement on the label will be similar to the burden of
adding the full domestic address or telephone number to the dietary
supplement label. We assume it will take 4 hours per label to assess
the current layout of each label and choose the best location for the
explanatory statement. Again we assume this label modification would
require one color change and that no premarket testing of the label
wording would be performed. FDA requests comments on how many dietary
supplement firms and products would follow FDA's recommendation to
include such an explanatory statement on the product's label. FDA also
requests comments on the burden associated with placing this
explanatory statement on the dietary supplement label.
The likely overestimate of the total burden caused by FDA's
conservative assumption that all dietary supplement labels (SKUs) will
be redesigned to add a domestic address or telephone number and to
include an explanatory statement for consumers is offset to some degree
by the underestimate of the number of SKUs in the marketplace resulting
from FDA's lack of information on the number of SKUs for dietary
supplements that are sold in a non-liquid or non-pill form. FDA
requests comments on the burden estimates presented in table 1 of this
document. The agency is especially interested in comments that include
information about: (1) The number of dietary supplements marketed in
the United States in all forms and (2) the number or percentage of
dietary supplements marketed in the United States that will not require
a label change to comply with the requirement that dietary supplements
bear a complete domestic address or telephone number. The agency would
also welcome information on whether dietary supplement firms plan to
add the recommended explanatory statement to their product labels.
III. 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
[[Page 200]]
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.
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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at https://www.cfsan.fda.gov/guidance.html.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-6266 Filed 12-27-07; 3:08 pm]
BILLING CODE 4160-01-S
