Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program, 3434-3435 [2016-01102]

Download as PDF 3434 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0294] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program AGENCY: Food and Drug Administration, HHS. ACTION: 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 February 22, 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, 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 0910–0495. 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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. SUMMARY: Food Contact Substance Notification Program;—21 CFR 170.101, 170.106, and 171.1 OMB Control Number 0910– 0495—Extension Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification process for food contact substances. Section 409(h)(6) of the FD&C Act defines a ‘‘food contact substance’’ as ‘‘any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.’’ Section 409(h)(3) of the FD&C Act requires that the notification process be used for authorizing the marketing of food contact substances except when: (1) We determine that the submission and premarket review of a food additive petition (FAP) under section 409(b) of the FD&C Act is necessary to provide adequate assurance of safety or (2) we and the manufacturer or supplier agree that an FAP should be submitted. Section 409(h)(1) of the FD&C Act requires that a notification include: (1) Information on the identity and the intended use of the food contact substance and (2) the basis for the manufacturer’s or supplier’s determination that the food contact substance is safe under the intended conditions of use. Sections 170.101 and 170.106 of FDA’s regulations (21 CFR 170.101 and 170.106) specify the information that a notification must contain and require that: (1) A food contact substance notification (FCN) includes Form FDA 3480 and (2) a notification for a food contact substance formulation includes Form FDA 3479. These forms serve to summarize pertinent information in the notification. The forms facilitate both preparation and review of notifications because the forms will serve to organize information necessary to support the safety of the use of the food contact substance. The burden of filling out the appropriate form has been included in the burden estimate for the notification. Currently, interested persons transmit an FCN submission to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3480 whether it is submitted in electronic or paper format. We estimate that the amount of time for respondents to complete Form FDA 3480 will continue to be the same. In addition to its required use with FCNs, Form FDA 3480 is recommended to be used to organize information within a Pre-notification Consultation or Master File submitted in support of an FCN according to the items listed on the form. Master Files can be used as repositories for information that can be referenced in multiple submissions to FDA, thus minimizing paperwork burden for food contact substance authorizations. We estimate that the amount of time for respondents to complete the Form FDA 3480 for these types of submissions is 0.5 hours. Section 171.1 of FDA’s regulations (21 CFR 171.1) specifies the information that a petitioner must submit in order to: (1) Establish that the proposed use of an indirect food additive is safe and (2) secure the publication of an indirect food additive regulation in parts 175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 describe the conditions under which the additive may be safely used. In addition, FDA’s guidance document entitled, ‘‘Use of Recycled Plastics in Food Packaging: Chemistry Considerations,’’ provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic. The recommendations in the guidance address the process by which manufacturers certify to us that their plastic products are safe for food contact. Description of Respondents: The respondents to this information collection are manufacturers of food contact substances. In the Federal Register of October 8, 2015 (80 FR 60911), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: asabaliauskas on DSK9F6TC42PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA Form No. 21 CFR Section or other category 170.106 2 (Category A) .................................. 170.101 3 7 (Category B) ................................ 170.101 4 7 (Category C) ................................ 170.101 5 7 (Category D) ................................ 170.101 6 7 (Category E) ................................ VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 FDA FDA FDA FDA FDA PO 00000 Number of responses per respondent Number of respondents 3479 3480 3480 3480 3480 Frm 00058 10 6 6 42 38 Fmt 4703 Sfmt 4703 Total annual responses 2 1 2 2 1 E:\FR\FM\21JAN1.SGM 20 6 12 84 38 21JAN1 Average burden per response 2 25 120 150 150 Total hours 40 150 1,440 12,600 5,700 3435 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent FDA Form No. Pre-notification Consultation or Master File (concerning a food contact substance).8 Amendment to an existing notification (170.101), amendment to a Pre-notification Consultation, or amendment to a Master File (concerning a food contact substance).9 171.1 Indirect Food Additive Petitions ........ Use of Recycled Plastics in Food Packaging: Chemistry Considerations. FDA 3480 190 1 190 0.5 95 FDA 3480A. 100 1 100 0.5 50 N/A ......... N/A ......... 1 10 1 1 1 10 ................ ........................ ........................ ........................ Total ........................................................ Number of respondents Average burden per response 21 CFR Section or other category Total annual responses Total hours 10,995 25 .......................... 10,995 250 31,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479 (‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 5 Notifications for uses that are the subject of moderately complex food additive petitions. 6 Notifications for uses that are the subject of very complex food additive petitions. 7 These notifications require the submission of Form FDA 3480. 8 These notifications recommend the submission of Form FDA 3480. 9 These notifications recommend the submission of Form FDA 3480A. asabaliauskas on DSK9F6TC42PROD with NOTICES 2 Notifications The estimates in table 1 are based on our current experience with the food contact substance notification program and informal communication with industry. Beginning in row 1 we estimate 10 respondents will submit two notifications annually for food contact substance formulations (Form FDA 3479), for a total of 20 responses. We calculate a reporting burden of 2 hours per response, for a total of 40 hours. In row 2 we estimate six respondents. We believe the hourly burden for preparing these notifications will primarily consist of the manufacturer or supplier completing Form FDA 3480, verifying that a previous notification is effective and preparing necessary documentation. We estimate one submission for each respondent, for a total of six responses. We calculate a reporting burden of 25 hours per response, for a total of 150 hours. In rows 3, 4, and 5 we identify three tiers of FCNs that reflect different levels of burden applicable to the respective information collection items (denoted as Categories C, D, and E). We estimate 6 respondents will submit 2 Category C submissions annually, for a total of 12 responses. We calculate a reporting burden of 120 hours per response, for a total burden of 1,440 hours. We estimate 42 respondents will submit 2 Category D submissions annually, for a total of 84 responses. We calculate a reporting burden of 150 hours per response, for a total burden of 12,600 hours. We estimate 38 respondents will submit 1Category E submission annually, for a total of 38 responses. We calculate a VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 reporting burden of 150 hours per response, for a total burden of 5,700 hours. In row 6 we estimate 190 respondents will submit information to a prenotification consultation or a master file in support of FCN submission using Form FDA 3480. We calculate a reporting burden of 0.5 hours per response, for a total burden of 95 hours. In row 7 we estimate 100 respondents will submit an amendment (Form FDA 3480A) to a substantive or nonsubstantive request of additional information to an incomplete FCN submission, an amendment to a prenotification consultation, or an amendment to a master file in support of an FCN. We calculate a reporting burden of 0.5 hours per response, for a total burden of 50 hours. In row 8 we estimate one respondent will submit one indirect food additive petition under § 171.1, for a total of one response. We calculate a reporting burden of 10,995 hours per response, for a total burden of 10,995 hours. Finally, in row 9 we estimate ten respondents will utilize the recommendations in the guidance document entitled, ‘‘Use of Recycled Plastics in Food Packaging: Chemistry Considerations,’’ to develop the additional information for one such submission annually, for a total of 10 responses. We calculate a reporting burden of 25 hours per response, for a total burden of 250 hours. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Dated: January 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01102 Filed 1–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–P–3319] Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire SUMMARY: E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3434-3435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01102]



[[Page 3434]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Contact 
Substance Notification Program

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 
February 22, 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, 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 0910-0495. 
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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Food Contact Substance Notification Program;--21 CFR 170.101, 170.106, 
and 171.1 OMB Control Number 0910-0495--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification 
process for food contact substances. Section 409(h)(6) of the FD&C Act 
defines a ``food contact substance'' as ``any substance intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.'' Section 409(h)(3) of the FD&C 
Act requires that the notification process be used for authorizing the 
marketing of food contact substances except when: (1) We determine that 
the submission and premarket review of a food additive petition (FAP) 
under section 409(b) of the FD&C Act is necessary to provide adequate 
assurance of safety or (2) we and the manufacturer or supplier agree 
that an FAP should be submitted. Section 409(h)(1) of the FD&C Act 
requires that a notification include: (1) Information on the identity 
and the intended use of the food contact substance and (2) the basis 
for the manufacturer's or supplier's determination that the food 
contact substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 
and 170.106) specify the information that a notification must contain 
and require that: (1) A food contact substance notification (FCN) 
includes Form FDA 3480 and (2) a notification for a food contact 
substance formulation includes Form FDA 3479. These forms serve to 
summarize pertinent information in the notification. The forms 
facilitate both preparation and review of notifications because the 
forms will serve to organize information necessary to support the 
safety of the use of the food contact substance. The burden of filling 
out the appropriate form has been included in the burden estimate for 
the notification.
    Currently, interested persons transmit an FCN submission to the 
Office of Food Additive Safety in the Center for Food Safety and 
Applied Nutrition using Form FDA 3480 whether it is submitted in 
electronic or paper format. We estimate that the amount of time for 
respondents to complete Form FDA 3480 will continue to be the same.
    In addition to its required use with FCNs, Form FDA 3480 is 
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN 
according to the items listed on the form. Master Files can be used as 
repositories for information that can be referenced in multiple 
submissions to FDA, thus minimizing paperwork burden for food contact 
substance authorizations. We estimate that the amount of time for 
respondents to complete the Form FDA 3480 for these types of 
submissions is 0.5 hours.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the 
information that a petitioner must submit in order to: (1) Establish 
that the proposed use of an indirect food additive is safe and (2) 
secure the publication of an indirect food additive regulation in parts 
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled, ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' provides 
assistance to manufacturers of food packaging in evaluating processes 
for producing packaging from post-consumer recycled plastic. The 
recommendations in the guidance address the process by which 
manufacturers certify to us that their plastic products are safe for 
food contact.
    Description of Respondents: The respondents to this information 
collection are manufacturers of food contact substances.
    In the Federal Register of October 8, 2015 (80 FR 60911), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Number of
      21 CFR Section or other category              FDA Form No.            Number of     responses per   Total annual   Average  burden    Total hours
                                                                           respondents     respondent       responses     per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A)...................  FDA 3479..................              10               2              20              2                40
170.101 \3\ \7\ (Category B)...............  FDA 3480..................               6               1               6             25               150
170.101 \4\ \7\ (Category C)...............  FDA 3480..................               6               2              12            120             1,440
170.101 \5\ \7\ (Category D)...............  FDA 3480..................              42               2              84            150            12,600
170.101 \6\ \7\ (Category E)...............  FDA 3480..................              38               1              38            150             5,700

[[Page 3435]]

 
Pre-notification Consultation or Master      FDA 3480..................             190               1             190              0.5              95
 File (concerning a food contact
 substance).\8\
Amendment to an existing notification        FDA 3480A.................             100               1             100              0.5              50
 (170.101), amendment to a Pre-notification
 Consultation, or amendment to a Master
 File (concerning a food contact
 substance).\9\
171.1 Indirect Food Additive Petitions.....  N/A.......................               1               1               1         10,995            10,995
Use of Recycled Plastics in Food Packaging:  N/A.......................              10               1              10             25               250
 Chemistry Considerations.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total..................................  ..........................  ..............  ..............  ..............  ...............          31,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
  (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The estimates in table 1 are based on our current experience with 
the food contact substance notification program and informal 
communication with industry.
    Beginning in row 1 we estimate 10 respondents will submit two 
notifications annually for food contact substance formulations (Form 
FDA 3479), for a total of 20 responses. We calculate a reporting burden 
of 2 hours per response, for a total of 40 hours. In row 2 we estimate 
six respondents. We believe the hourly burden for preparing these 
notifications will primarily consist of the manufacturer or supplier 
completing Form FDA 3480, verifying that a previous notification is 
effective and preparing necessary documentation. We estimate one 
submission for each respondent, for a total of six responses. We 
calculate a reporting burden of 25 hours per response, for a total of 
150 hours.
    In rows 3, 4, and 5 we identify three tiers of FCNs that reflect 
different levels of burden applicable to the respective information 
collection items (denoted as Categories C, D, and E). We estimate 6 
respondents will submit 2 Category C submissions annually, for a total 
of 12 responses. We calculate a reporting burden of 120 hours per 
response, for a total burden of 1,440 hours. We estimate 42 respondents 
will submit 2 Category D submissions annually, for a total of 84 
responses. We calculate a reporting burden of 150 hours per response, 
for a total burden of 12,600 hours. We estimate 38 respondents will 
submit 1Category E submission annually, for a total of 38 responses. We 
calculate a reporting burden of 150 hours per response, for a total 
burden of 5,700 hours.
    In row 6 we estimate 190 respondents will submit information to a 
pre-notification consultation or a master file in support of FCN 
submission using Form FDA 3480. We calculate a reporting burden of 0.5 
hours per response, for a total burden of 95 hours. In row 7 we 
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a 
substantive or non-substantive request of additional information to an 
incomplete FCN submission, an amendment to a pre-notification 
consultation, or an amendment to a master file in support of an FCN. We 
calculate a reporting burden of 0.5 hours per response, for a total 
burden of 50 hours.
    In row 8 we estimate one respondent will submit one indirect food 
additive petition under Sec.  171.1, for a total of one response. We 
calculate a reporting burden of 10,995 hours per response, for a total 
burden of 10,995 hours.
    Finally, in row 9 we estimate ten respondents will utilize the 
recommendations in the guidance document entitled, ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' to develop the 
additional information for one such submission annually, for a total of 
10 responses. We calculate a reporting burden of 25 hours per response, 
for a total burden of 250 hours.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01102 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P