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]

Download as PDF 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: VerDate Sep<11>2014 18:25 Oct 25, 2016 Jkt 241001 SUPPLEMENTARY INFORMATION: Dated: October 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25853 Filed 10–25–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 http://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 E:\FR\FM\26OCN1.SGM 26OCN1

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]


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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 http://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