Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 74453-74454 [2016-25793]
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74453
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices
year. We estimated that these SKUs are
marketed by 300 manufacturers. We
estimated that the preparation of
labeling for new OTC drug products
would require 12 hours to prepare,
complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is
approximately 10,800 hours.
All currently marketed sunscreen
products are required to be in
compliance with the Drug Facts labeling
requirements in § 201.66, and thus will
incur no further burden under the
information collection provisions in the
1999 labeling final rule. However, a new
OTC sunscreen drug product, like any
new OTC drug product, will be subject
to a one-time burden to comply with
Drug Facts labeling requirements in
§ 201.66. We estimate that 60 new SKUs
of OTC sunscreen drug products would
be marketed each year (77 FR 27230 at
27234). We estimate that these 60 SKUs
would be marketed by 20
manufacturers. We estimate that
approximately 12 hours would be spent
on each label, based on the most recent
estimate used for other OTC drug
products to comply with the 1999 Drug
Facts labeling final rule, including
public comments received on this
estimate in 2010 that addressed
sunscreens.
In determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e).
Since publication of the 1999 labeling
final rule, we have received only one
request for exemption or deferral. One
response over a 10-year period equates
to an annual frequency of response
equal to 0.1. In the 1999 labeling final
rule, we estimated that a request for
deferral or exemption would require 24
hours to complete (64 FR 13254 at
13276). We continue to estimate that
this type of response will require
approximately 24 hours. Multiplying
the annual frequency of response (0.1)
by the number of hours per response
(24) gives a total response time for
requesting exemption of deferral equal
to 3 hours.
In the Federal Register of April 1,
2016 (81 FR 18861), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
201.66(c) and (d) for new OTC drug products ....................
201.66(c) and (d) for new OTC sunscreen products ..........
201.66(e) ..............................................................................
300
20
1
3
3
0.125
900
60
.125
12
12
24
10,800
720
3
Total ..............................................................................
........................
........................
........................
........................
11,523
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
after the publication of the notice of the
workshop. This document corrects that
error.
[FR Doc. 2016–25854 Filed 10–25–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Chris Nguyen, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124,
Silver Spring, MD 20993–0002; or
Cynthia Whitmarsh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993–0002.
[Docket No. FDA–2013–N–0730]
In the
Federal Register of September 1, 2016,
in FR Doc. 2016–21046, on page 60357,
the following correction is made:
On page 60357, in the third column
under the SUPPLEMENTARY INFORMATION
caption, the fifth sentence in the second
paragraph is corrected to read ‘‘More
information can be found at: https://
www.sentinelsystem.org/vaccines-bloodbiologics.’’
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
Program; Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Thursday, September 1, 2016
(81 FR 60357). The document
announced a public workshop entitled
‘‘The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
(PRISM) Program.’’ The document was
published with a Web site that changed
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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SUPPLEMENTARY INFORMATION:
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25853 Filed 10–25–16; 8:45 am]
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PO 00000
Frm 00063
Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
25, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
SUMMARY:
E:\FR\FM\26OCN1.SGM
26OCN1
74454
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0298. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Threshold of Regulation for Substances
Used in Food-Contact Articles—21 CFR
170.39 (OMB Control Number 0910–
0298)—Extension
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)), the use of
a food additive is deemed unsafe unless
one of the following is applicable: (1) It
conforms to an exemption for
investigational use under section 409(j)
of the FD&C Act; (2) it conforms to the
terms of a regulation prescribing its use;
or (3) in the case of a food additive
which meets the definition of a foodcontact substance in section 409(h)(6) of
the FD&C Act, there is either a
regulation authorizing its use in
accordance with section 409(a)(3)(A) or
an effective notification in accordance
with section 409(a)(3)(B).
The regulations in § 170.39 (21 CFR
170.39) established a process that
provides the manufacturer with an
opportunity to demonstrate that the
likelihood or extent of migration to food
of a substance used in a food-contact
article is so trivial that the use need not
be the subject of a food additive listing
regulation or an effective notification.
The Agency has established two
thresholds for the regulation of
substances used in food-contact articles.
The first exempts those substances used
in food-contact articles where the
resulting dietary concentration would
be at or below 0.5 parts per billion. The
second exempts regulated direct food
additives for use in food-contact articles
where the resulting dietary exposure is
1 percent or less of the acceptable daily
intake for these substances.
In order to determine whether the
intended use of a substance in a foodcontact article meets the threshold
criteria, certain information specified in
§ 170.39(c) must be submitted to FDA.
This information includes the following
components: (1) The chemical
composition of the substance for which
the request is made, (2) detailed
information on the conditions of use of
the substance, (3) a clear statement of
the basis for the request for exemption
from regulation as a food additive, (4)
data that will enable FDA to estimate
the daily dietary concentration resulting
from the proposed use of the substance,
(5) results of a literature search for
toxicological data on the substance and
its impurities, and (6) information on
the environmental impact that would
result from the proposed use.
FDA uses this information to
determine whether the food-contact
article meets the threshold criteria.
Respondents to this information
collection are individual manufacturers
and suppliers of substances used in
food-contact articles (i.e., food
packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of May 11,
2016 (81 FR 29271), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 170.39
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Threshold of regulation for substances used in food-contact articles .......................................................................
7
1
7
48
336
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, we
consulted our records of the number of
regulation exemption requests received
in the past 3 years. The annual hours
per response reporting estimate of 48
hours is based on information received
from representatives of the food
packaging and processing industries and
Agency records.
We estimate that approximately 7
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39, for a
total of 336 hours. The threshold of
regulation process offers one advantage
over the premarket notification process
for food-contact substances established
by section 409(h) of the FD&C Act (OMB
control number 0910–0495) in that the
use of a substance exempted by FDA is
VerDate Sep<11>2014
18:25 Oct 25, 2016
Jkt 241001
not limited to only the manufacturer or
supplier who submitted the request for
an exemption. Other manufacturers or
suppliers may use exempted substances
in food-contact articles as long as the
conditions of use (e.g., use levels,
temperature, type of food contacted,
etc.) are those for which the exemption
was issued. As a result, the overall
burden on both Agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and we would not have
to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances which is on
display at FDA’s Division of Dockets
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Management and on the Internet at
https://www.fda.gov/Food/
IngredientsPackagingLabeling/
PackagingFCS/
ThresholdRegulationExemptions/
ucm093685.htm. Having the list of
exempted substances publicly available
decreases the likelihood that a company
would submit a food additive petition or
a notification for the same type of foodcontact application of a substance for
which the Agency has previously
granted an exemption from the food
additive listing regulation requirement.
Dated: October 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25793 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74453-74454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0730]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Threshold of
Regulation for Substances Used in Food-Contact Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 25, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs,
[[Page 74454]]
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
oira_submission@omb.eop.gov. All comments should be identified with the
OMB control number 0910-0298. Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Threshold of Regulation for Substances Used in Food-Contact Articles--
21 CFR 170.39 (OMB Control Number 0910-0298)--Extension
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(a)), the use of a food additive is deemed
unsafe unless one of the following is applicable: (1) It conforms to an
exemption for investigational use under section 409(j) of the FD&C Act;
(2) it conforms to the terms of a regulation prescribing its use; or
(3) in the case of a food additive which meets the definition of a
food-contact substance in section 409(h)(6) of the FD&C Act, there is
either a regulation authorizing its use in accordance with section
409(a)(3)(A) or an effective notification in accordance with section
409(a)(3)(B).
The regulations in Sec. 170.39 (21 CFR 170.39) established a
process that provides the manufacturer with an opportunity to
demonstrate that the likelihood or extent of migration to food of a
substance used in a food-contact article is so trivial that the use
need not be the subject of a food additive listing regulation or an
effective notification. The Agency has established two thresholds for
the regulation of substances used in food-contact articles. The first
exempts those substances used in food-contact articles where the
resulting dietary concentration would be at or below 0.5 parts per
billion. The second exempts regulated direct food additives for use in
food-contact articles where the resulting dietary exposure is 1 percent
or less of the acceptable daily intake for these substances.
In order to determine whether the intended use of a substance in a
food-contact article meets the threshold criteria, certain information
specified in Sec. 170.39(c) must be submitted to FDA. This information
includes the following components: (1) The chemical composition of the
substance for which the request is made, (2) detailed information on
the conditions of use of the substance, (3) a clear statement of the
basis for the request for exemption from regulation as a food additive,
(4) data that will enable FDA to estimate the daily dietary
concentration resulting from the proposed use of the substance, (5)
results of a literature search for toxicological data on the substance
and its impurities, and (6) information on the environmental impact
that would result from the proposed use.
FDA uses this information to determine whether the food-contact
article meets the threshold criteria. Respondents to this information
collection are individual manufacturers and suppliers of substances
used in food-contact articles (i.e., food packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of May 11, 2016 (81 FR 29271), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR 170.39 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold of regulation for substances used in food-contact 7 1 7 48 336
articles..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, we consulted our records of the
number of regulation exemption requests received in the past 3 years.
The annual hours per response reporting estimate of 48 hours is based
on information received from representatives of the food packaging and
processing industries and Agency records.
We estimate that approximately 7 requests per year will be
submitted under the threshold of regulation exemption process of Sec.
170.39, for a total of 336 hours. The threshold of regulation process
offers one advantage over the premarket notification process for food-
contact substances established by section 409(h) of the FD&C Act (OMB
control number 0910-0495) in that the use of a substance exempted by
FDA is not limited to only the manufacturer or supplier who submitted
the request for an exemption. Other manufacturers or suppliers may use
exempted substances in food-contact articles as long as the conditions
of use (e.g., use levels, temperature, type of food contacted, etc.)
are those for which the exemption was issued. As a result, the overall
burden on both Agency and the regulated industry would be significantly
less in that other manufacturers and suppliers would not have to
prepare, and we would not have to review, similar submissions for
identical components of food-contact articles used under identical
conditions. Manufacturers and other interested persons can easily
access an up-to-date list of exempted substances which is on display at
FDA's Division of Dockets Management and on the Internet at https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/ThresholdRegulationExemptions/ucm093685.htm. Having the list of
exempted substances publicly available decreases the likelihood that a
company would submit a food additive petition or a notification for the
same type of food-contact application of a substance for which the
Agency has previously granted an exemption from the food additive
listing regulation requirement.
Dated: October 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25793 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P
