Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 35687-35688 [2012-14487]
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35687
Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14483 Filed 6–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0564]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dietary
Supplement Labeling Requirements
and Recommendations Under the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (the DSNDCPA) and the
guidance document 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.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 13, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
SUMMARY:
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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,
including each proposed extension of an
existing 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
comments 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 of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Dietary Supplement Labeling
Requirements and Recommendations
Under the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act—(OMB Control Number
0910–0642)—Extension
In 2006, the DSNDCPA (Pub. L. 109–
462, 120 Stat. 3469) amended 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. The DSNDCPA also
amended the FD&C Act to add section
403(y) (21 U.S.C. 343(y)), which
requires the label of a dietary
supplement marketed in the United
States to include a domestic address or
domestic telephone number through
which the product’s manufacturer,
packer, or distributor may receive a
report of a serious adverse event
associated with the dietary supplement.
In the Federal Register of September
1, 2009 (74 FR 45221), FDA announced
the availability of a guidance document
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.’’ The guidance
document contains questions and
answers related to the labeling
requirements in section 403(y) of the
FD&C Act and provides guidance to
industry on the use of an explanatory
statement before the domestic address
or telephone number. The guidance
document provides the Agency’s
interpretation of the labeling
requirements for section 403(y) of the
FD&C Act and the Agency’s views on
the information that should be included
on the label. The Agency believes that
the guidance will enable persons to
meet the criteria for labeling that are
established in section 403(y) of the
FD&C Act.
FDA estimates the burden of this
collection of information as follows:
pmangrum on DSK3VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Domestic address or phone number labeling requirement
(21 U.S.C. 343(y)) ............................................................
FDA recommendation for label statement explaining purpose of domestic address or phone number ...................
VerDate Mar<15>2010
14:34 Jun 13, 2012
Jkt 226001
PO 00000
Frm 00031
Number of
disclosures
per
respondent 2
Total annual
disclosures
Average
burden per
disclosure
Total hours
1,460
3.8
5,560
0.5
2,780
1,460
3.8
5,560
0.5
2,780
Fmt 4703
Sfmt 4703
E:\FR\FM\14JNN1.SGM
14JNN1
35688
Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Number of
disclosures
per
respondent 2
Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
........................
Activity
Total ..............................................................................
Total hours
5,560
1 There
pmangrum on DSK3VPTVN1PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Number has been rounded to the nearest tenth.
The labeling requirements of section
403(y) of the FD&C Act became effective
on December 22, 2007, although FDA
exercised enforcement discretion until
September 30, 2010, to enable all firms
to meet the labeling requirements for
dietary supplements. FDA estimates that
all labels required to include the
domestic address or telephone number
pursuant to section 403(y) of the FD&C
Act have been revised by the effective
date. Thus, in succeeding years, the
Agency estimates that the burden hours
associated with the labeling
requirements of section 403(y) of the
FD&C Act and the Agency’s
recommendations on the use of an
explanatory statement will apply only to
new product labels. Based on the A.C.
Nielsen Sales Scanner Data, FDA
estimated that the number of dietary
supplement SKUs for which sales of the
products are greater than zero is 55,600.
Assuming that the flow of new products
is 10 percent per year, then
approximately 5,560 new dietary
supplement products will come on the
market each year. FDA also estimates
that there are about 1,460 dietary
supplement manufacturers, repackagers, re-labelers, and holders of
dietary supplements. Assuming the
approximately 5,560 new products are
split equally among the firms, then each
firm would prepare labels for close to
four new products per year (5,560 new
products/1,460 firms is approximately
3.8 labels per firm). Thus, the estimated
total annual disclosures are 5,560 (1,460
firms × 3.8 labels per year = 5,560).
The Agency expects that firms
prepare the required labeling for their
products in a manner that takes into
account at one time all information
required to be disclosed on their
product labels. Based upon its
knowledge of food and dietary
supplement labeling, FDA estimates that
firms would require less than 0.5 hour
per product to comply with the
requirement to include the domestic
address or telephone number pursuant
to section 403(y) of the FD&C Act. The
total hour burden of this task is shown
in row 1 of table 1.
FDA estimates that all firms will
include an explanatory statement on the
VerDate Mar<15>2010
14:34 Jun 13, 2012
Jkt 226001
label, which lets consumers know the
purpose of the domestic address or
telephone number on the label of the
dietary supplement product. Based
upon its knowledge of food and dietary
supplement labeling, FDA estimates that
firms would require less than 0.5 hour
per product to comply with the
Agency’s recommendations on the use
of an explanatory statement. The total
hour burden of this task is shown in row
2 of table 1.
The total reporting hour burden is
5,560 hours, which equals the burden
for the required domestic address or
telephone (2,780) plus the burden for
the explanatory statement before the
domestic address or telephone number
(2,780).
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14487 Filed 6–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Draft and Revised Draft Guidances for
Industry Describing Product-Specific
Bioequivalence Recommendations;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of additional draft and
revised draft product-specific
bioequivalence (BE) recommendations.
The recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of June 11, 2010 (75 FR 33311),
FDA announced the availability of a
guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
available to the public on FDA’s Web
site. The BE recommendations
identified in this notice were developed
using the process described in that
guidance.
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 these draft
and revised draft guidances before it
begins work on the final versions of the
guidances, submit either electronic or
written comments on the draft and
revised draft product-specific BE
recommendations listed in this notice
by August 13, 2012.
ADDRESSES: Submit written requests for
single copies of the individual BE
guidances to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance recommendations.
Submit electronic comments on the
draft product-specific BE
recommendations to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: K.
Geoffrey Wu, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9326.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010, FDA announced the availability of
a guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35687-35688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0564]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Dietary Supplement Labeling Requirements and
Recommendations Under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (the DSNDCPA) and the guidance document 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.''
DATES: Submit either electronic or written comments on the collection
of information by August 13, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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, including
each proposed extension of an existing 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 comments 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 of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Dietary Supplement Labeling Requirements and Recommendations Under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act--
(OMB Control Number 0910-0642)--Extension
In 2006, the DSNDCPA (Pub. L. 109-462, 120 Stat. 3469) amended 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. The
DSNDCPA also amended the FD&C Act to add section 403(y) (21 U.S.C.
343(y)), which requires the label of a dietary supplement marketed in
the United States to include a domestic address or domestic telephone
number through which the product's manufacturer, packer, or distributor
may receive a report of a serious adverse event associated with the
dietary supplement.
In the Federal Register of September 1, 2009 (74 FR 45221), FDA
announced the availability of a guidance document 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.'' The guidance document contains
questions and answers related to the labeling requirements in section
403(y) of the FD&C Act and provides guidance to industry on the use of
an explanatory statement before the domestic address or telephone
number. The guidance document provides the Agency's interpretation of
the labeling requirements for section 403(y) of the FD&C Act and the
Agency's views on the information that should be included on the label.
The Agency believes that the guidance will enable persons to meet the
criteria for labeling that are established in section 403(y) of the
FD&C Act.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
Activity respondents per disclosures burden per Total hours
respondent \2\ disclosure
----------------------------------------------------------------------------------------------------------------
Domestic address or phone number 1,460 3.8 5,560 0.5 2,780
labeling requirement (21 U.S.C.
343(y))........................
FDA recommendation for label 1,460 3.8 5,560 0.5 2,780
statement explaining purpose of
domestic address or phone
number.........................
-------------------------------------------------------------------------------
[[Page 35688]]
Total....................... .............. .............. .............. .............. 5,560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Number has been rounded to the nearest tenth.
The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although FDA exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. FDA estimates that all
labels required to include the domestic address or telephone number
pursuant to section 403(y) of the FD&C Act have been revised by the
effective date. Thus, in succeeding years, the Agency estimates that
the burden hours associated with the labeling requirements of section
403(y) of the FD&C Act and the Agency's recommendations on the use of
an explanatory statement will apply only to new product labels. Based
on the A.C. Nielsen Sales Scanner Data, FDA estimated that the number
of dietary supplement SKUs for which sales of the products are greater
than zero is 55,600. Assuming that the flow of new products is 10
percent per year, then approximately 5,560 new dietary supplement
products will come on the market each year. FDA also estimates that
there are about 1,460 dietary supplement manufacturers, re-packagers,
re-labelers, and holders of dietary supplements. Assuming the
approximately 5,560 new products are split equally among the firms,
then each firm would prepare labels for close to four new products per
year (5,560 new products/1,460 firms is approximately 3.8 labels per
firm). Thus, the estimated total annual disclosures are 5,560 (1,460
firms x 3.8 labels per year = 5,560).
The Agency expects that firms prepare the required labeling for
their products in a manner that takes into account at one time all
information required to be disclosed on their product labels. Based
upon its knowledge of food and dietary supplement labeling, FDA
estimates that firms would require less than 0.5 hour per product to
comply with the requirement to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act. The total
hour burden of this task is shown in row 1 of table 1.
FDA estimates that all firms will include an explanatory statement
on the label, which lets consumers know the purpose of the domestic
address or telephone number on the label of the dietary supplement
product. Based upon its knowledge of food and dietary supplement
labeling, FDA estimates that firms would require less than 0.5 hour per
product to comply with the Agency's recommendations on the use of an
explanatory statement. The total hour burden of this task is shown in
row 2 of table 1.
The total reporting hour burden is 5,560 hours, which equals the
burden for the required domestic address or telephone (2,780) plus the
burden for the explanatory statement before the domestic address or
telephone number (2,780).
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14487 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P
