Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 4153-4154 [2013-01031]
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4153
Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
21 CFR Section
Number of recordkeepers
§ 129.35(a)(3)(i), § 129.80(h)
319 (bottlers subject to
source water and finished
product testing).
95 (bottlers testing finished
product only).
3 (bottlers conducting secondary testing of source
water).
3 (bottlers rectifying contamination).
6
1,914
0.08
153
3
285
0.08
23
5
15
0.08
1.2
3
9
.25
2
...............................................
..............................
..............................
..............................
179
§ 129.80(g), § 129.80(h) ........
§ 129.35(a)(3)(i), § 129.80(h)
§ 129.35(a)(3)(i), § 129.80(h)
Total Annual Burden .....
mstockstill on DSK4VPTVN1PROD with
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
We therefore conclude that any
additional burden and costs in
recordkeeping based on followup testing
that is required if any coliform
organisms detected in the source water
test positive for E. coli are negligible.
We estimate that the labor burden of
keeping records of each test is about 5
minutes per test. We also require
followup testing of source water and
finished bottled water products for E.
coli when total coliform positives occur.
We expect that 319 bottlers that use
sources other than PWSs may find a
total coliform positive sample about 3
times per year in source testing and
about three times in finished product
testing, for a total of 153 hours of
recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs
may find a total coliform positive
sample about 3 times per year in
finished product testing, for a total of 23
hours of recordkeeping. Upon finding a
total coliform sample, bottlers will then
have to conduct a followup test for E.
coli.
We expect that recordkeeping for the
followup test for E. coli will also take
about 5 minutes per test. As shown in
table 1 of this document, we expect that
3 bottlers per year will have to carry out
the additional E. coli testing, with a
burden of 1 hour. These bottlers will
also have to keep records about
rectifying the source contamination, for
a burden of 2 hours. For all expected
total coliform testing, E. coli testing, and
source rectification, we estimate a total
burden of 179 hours. We base our
estimate on our experience with the
current CGMP regulations.
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16:52 Jan 17, 2013
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Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01032 Filed 1–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0032]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
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. 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 invites comments on
the information collection provisions of
the regulation requiring manufacturers,
packers, and distributors of dietary
supplements to notify us that they are
marketing a dietary supplement product
that bears on its label or in its labeling
a statement provided for in the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by March 19, 2013.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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.
ADDRESSES:
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, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
(2) the accuracy of our 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.
Food Labeling; Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93 (OMB
Control Number 0910–0331—Extension)
Section 403(r)(6) of the FD&C Act (21
U.S.C. 343(r)(6)) requires that FDA be
notified by manufacturers, packers, and
distributors of dietary supplements that
they are marketing a dietary supplement
product that bears on its label or in its
labeling a statement provided for in
section 403(r)(6) of the FD&C Act.
Section 403(r)(6) of the FD&C Act
requires that FDA be notified, with a
submission about such statements, no
later than 30 days after the first
marketing of the dietary supplement.
Information that is required in the
submission includes: (1) The name and
address of the manufacturer, packer, or
distributor of the dietary supplement
product; (2) the text of the statement
that is being made; (3) the name of the
dietary ingredient or supplement that is
the subject of the statement; (4) the
name of the dietary supplement
(including the brand name); and (5) a
signature of a responsible individual
who can certify the accuracy of the
information presented, and who must
certify that the information contained in
the notice is complete and accurate, and
that the notifying firm has
substantiation that the statement is
truthful and not misleading.
The procedural regulation for this
program is codified at § 101.93 (21 CFR
101.93). Section 101.93 provides
submission procedures and identifies
the information that must be included
in order to meet the requirements of
section 403 of the FD&C Act.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
101.93 ..................................................................................
2,200
1
2,200
0.75
1,650
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal
burden on the industry to generate
information to meet the requirements of
section 403 of the FD&C Act in
submitting information regarding
section 403(r)(6) of the FD&C Act
statements on labels or in labeling of
dietary supplements. We are requesting
only information that is immediately
available to the manufacturer, packer, or
distributor of the dietary supplement
that bears such a statement on its label
or in its labeling. We estimate that, each
year, approximately 2,200 firms will
submit the information required by
section 403 of the FD&C Act. We
estimate that a firm will require 0.75
hours to gather the information needed
and prepare a submission, for a total of
1,650 hours (2,200 × 0.75). This estimate
is based on the average number of
notification submissions received by us
in the preceding 3 years.
Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01031 Filed 1–17–13; 8:45 am]
mstockstill on DSK4VPTVN1PROD with
BILLING CODE 4160–01–P
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16:52 Jan 17, 2013
Jkt 229001
DEPARTMENT OF HOMELAND
SECURITY
[DHS–2011–0108]
RIN 1601–ZA11
Identification of Foreign Countries
Whose Nationals Are Eligible To
Participate in the H–2A and H–2B
Nonimmigrant Worker Programs
Office of the Secretary, DHS.
Notice.
AGENCY:
ACTION:
Under Department of
Homeland Security (DHS) regulations,
U.S. Citizenship and Immigration
Services (USCIS) may approve petitions
for H–2A and H–2B nonimmigrant
status only for nationals of countries
that the Secretary of Homeland Security,
with the concurrence of the Secretary of
State, has designated by notice
published in the Federal Register. That
notice must be renewed each year. This
notice announces that the Secretary of
Homeland Security, in consultation
with the Secretary of State, is
identifying 59 countries whose
nationals are eligible to participate in
the H–2A and H–2B programs for the
coming year. The list published today
includes one new addition: Grenada.
DATES: Effective Date: This notice is
effective January 18, 2013, and shall be
without effect at the end of one year
after January 18, 2013.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Francis Cissna, Office of Policy,
Department of Homeland Security,
Washington, DC 20528, (202) 447–3835.
SUPPLEMENTARY INFORMATION:
Background: Generally, USCIS may
approve H–2A and H–2B petitions for
nationals of only those countries that
the Secretary of Homeland Security,
with the concurrence of the Secretary of
State, has designated as participating
countries. Such designation must be
published as a notice in the Federal
Register and expires after one year.
USCIS, however, may allow a national
from a country not on the list to be
named as a beneficiary of an H–2A or
H–2B petition based on a determination
that such participation is in the U.S.
interest. See 8 CFR 214.2(h)(5)(i)(F) and
8 CFR 214.2(h)(6)(i)(E).
In designating countries to include on
the list, the Secretary of Homeland
Security, with the concurrence of the
Secretary of State, will take into account
factors including, but not limited to: (1)
The country’s cooperation with respect
to issuance of travel documents for
citizens, subjects, nationals, and
residents of that country who are subject
to a final order of removal; (2) the
number of final and unexecuted orders
of removal against citizens, subjects,
nationals, and residents of that country;
(3) the number of orders of removal
executed against citizens, subjects,
E:\FR\FM\18JAN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4153-4154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0032]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling; Notification Procedures for Statements
on Dietary Supplements
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. 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
invites comments on the information collection provisions of the
regulation requiring manufacturers, packers, and distributors of
dietary supplements to notify us that they are marketing a dietary
supplement product that bears on its label or in its labeling a
statement provided for in the Federal Food, Drug, and Cosmetic Act (the
FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by March 19, 2013.
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, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility;
[[Page 4154]]
(2) the accuracy of our 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.
Food Labeling; Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331--Extension)
Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires
that FDA be notified by manufacturers, packers, and distributors of
dietary supplements that they are marketing a dietary supplement
product that bears on its label or in its labeling a statement provided
for in section 403(r)(6) of the FD&C Act. Section 403(r)(6) of the FD&C
Act requires that FDA be notified, with a submission about such
statements, no later than 30 days after the first marketing of the
dietary supplement. Information that is required in the submission
includes: (1) The name and address of the manufacturer, packer, or
distributor of the dietary supplement product; (2) the text of the
statement that is being made; (3) the name of the dietary ingredient or
supplement that is the subject of the statement; (4) the name of the
dietary supplement (including the brand name); and (5) a signature of a
responsible individual who can certify the accuracy of the information
presented, and who must certify that the information contained in the
notice is complete and accurate, and that the notifying firm has
substantiation that the statement is truthful and not misleading.
The procedural regulation for this program is codified at Sec.
101.93 (21 CFR 101.93). Section 101.93 provides submission procedures
and identifies the information that must be included in order to meet
the requirements of section 403 of the FD&C Act.
Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the FD&C Act statements on
their labels or labeling.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.93............................................................. 2,200 1 2,200 0.75 1,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal burden on the industry to
generate information to meet the requirements of section 403 of the
FD&C Act in submitting information regarding section 403(r)(6) of the
FD&C Act statements on labels or in labeling of dietary supplements. We
are requesting only information that is immediately available to the
manufacturer, packer, or distributor of the dietary supplement that
bears such a statement on its label or in its labeling. We estimate
that, each year, approximately 2,200 firms will submit the information
required by section 403 of the FD&C Act. We estimate that a firm will
require 0.75 hours to gather the information needed and prepare a
submission, for a total of 1,650 hours (2,200 x 0.75). This estimate is
based on the average number of notification submissions received by us
in the preceding 3 years.
Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01031 Filed 1-17-13; 8:45 am]
BILLING CODE 4160-01-P
