Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions-Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503, 52353-52354 [2020-18602]

Download as PDF Federal Register / Vol. 85, No. 165 / Tuesday, August 25, 2020 / Notices achieve placement in a safe setting that is the least restrictive, most family-like setting available and in close proximity to the child’s parental home, consistent with the best interest and special needs of the child. States, territories, and tribes meeting these requirements also partly comply with title IV–B, section 422(b), of the Act, which assures certain protections for children in foster care. The case plan is a written document that provides a narrative description of the child-specific program of care. Federal regulations at 45 CFR 1356.21(g) and sections 475 and 475A of the Act delineate the specific information that must be addressed in the case plan. ACF 52353 does not specify a format for the case plan nor does ACF require submission of the document to the federal government. Case plan information is recorded in a format developed and maintained by the state, territorial, or tribal title IV–E agency. Respondents: State, territorial, and tribal title IV–E agencies. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Total number of responses per respondent Average burden hours per response Total burden hours Annual burden hours Case Plan ............................................................................ 64 26,427 4.8 8,118,374 2,706,125 Estimated Total Annual Burden Hours: 2,706,125. Authority: 42 U.S.C. 622; 42 U.S.C. 671; 42 U.S.C. 675. John M. Sweet Jr., ACF/OPRE Certifying Officer. [FR Doc. 2020–18652 Filed 8–24–20; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4184–01–P Food and Drug Administration Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. [Docket No. FDA–2020–N–0908] SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions—Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 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: Submit written comments (including recommendations) on the collection of information by September 24, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0016. Also include the FDA docket number found in brackets in the heading of this document. VerDate Sep<11>2014 19:55 Aug 24, 2020 Jkt 250001 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Submission of Petitions: Food Additive, Color Additive (Including Labeling); Submission of Information to a Master File in Support of Petitions; Electronic Submission Using Form FDA 3503—21 CFR 70.25, 71.1, 171.1, 172, 173, 179, and 180 OMB Control Number 0910–0016— Revision Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe, unless: (1) The additive and its use, or intended use, are in conformity with a regulation issued under section 409 that describes the condition(s) under which the additive may be safely used; (2) the additive and its use, or intended use, conform to the terms of an exemption for investigational use; or (3) a food contact notification submitted under section 409(h) of the FD&C Act is effective. Food additive petitions (FAPs) are submitted by individuals or companies to obtain approval of a new food additive or to amend the conditions of use permitted under an PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 existing food additive regulation. Section 171.1 of FDA’s regulations (21 CFR 171.1) specifies the information that a petitioner must submit to establish that the proposed use of a food additive is safe and to secure the publication of a food additive regulation describing the conditions under which the additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling requirements for certain food additives to ensure their safe use. Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a color additive shall be deemed to be unsafe unless the additive and its use are in conformity with a regulation that describes the condition(s) under which the additive may safely be used, or the additive and its use conform to the terms of an exemption for investigational use issued under section 721(f) of the FD&C Act. Color additive petitions (CAPs) are submitted by individuals or companies to obtain approval of a new color additive or a change in the conditions of use permitted for a color additive that is already approved. Section 71.1 of the Agency’s regulations (21 CFR 71.1) specifies the information that a petitioner must submit to establish the safety of a color additive and to secure the issuance of a regulation permitting its use. FDA’s color additive labeling requirements in § 70.25 (21 CFR 70.25) require that color additives that are to be used in food, drugs, devices, or cosmetics be labeled with sufficient information to ensure their safe use. FDA scientific personnel reviews FAPs to ensure the safety of the intended use of the additive in or on food, or that may be present in food as a result of its use in articles that contact food. Likewise, FDA personnel review CAPs to ensure the safety of the color E:\FR\FM\25AUN1.SGM 25AUN1 52354 Federal Register / Vol. 85, No. 165 / Tuesday, August 25, 2020 / Notices additive prior to its use in food, drugs, cosmetics, or medical devices. Respondents may transmit FAP or CAP regulatory submissions in electronic format or paper format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition (CFSAN) using Form FDA 3503. Form FDA 3503 helps the respondent organize their submission to focus on the information needed for FDA’s safety review. Form FDA 3503 can also be used to organize information within a master file submitted in support of petitions 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 the Agency, thus minimizing paperwork burden for food and color additive approvals. FDA estimates that the amount of time for respondents to complete Form FDA 3503 will continue to be 1 hour. We are revising the information collection to reflect ongoing modernization efforts. We have augmented our FDA Unified Registration and Listing System (FURLS) with the CFSAN Online Submission Module (COSM). COSM provides a real-time user interface process we believe will assist respondents in preparing and making submissions to Offices in CFSAN. COSM is a web-based tool that supports electronic submissions, thereby eliminating the need for printing and mailing of paper submissions. COSM is available 24 hours a day and seven days a week. Information submitted to COSM is the same information respondents would submit to FURLS. Information about COSM, including user instruction, is available on the internet at: https:// www.fda.gov/food/registration-foodfacilities-and-other-submissions/cfsanonline-submission-module-cosm. Description of Respondents: Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food. In the Federal Register of March 17, 2020 (85 FR 15188), we published a 60day 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 responses per respondent Number of respondents 21 CFR section; form Average burden per response Total annual responses Total hours Total operating and maintenance costs CAP 70.25, 71.1 ............................................... 2 1 2 1,337 2,674 $5,600 FAPs 171.1 ........................................................ Form FDA 3503 ....................................... 3 6 1 1 3 6 7,093 1 21,279 6 0 0 Total .................................................. ........................ ........................ ........................ ........................ 23,959 5,600 khammond on DSKJM1Z7X2PROD with NOTICES 1 There are no capital costs associated with this collection of information. Our estimate of burden attributable to FAPs or CAPs is based on our experience with the information collection, which has not changed since our last review, and we therefore retain the currently approved burden. This estimate reflects the average number of petitions we have received annually over a period of 10 years. The attendant burden we estimate also reflects an industry average, although burden associated with individual petitions may vary depending on the complexity of the petition, and the amount and type of data needed for scientific analysis. CAPs are subject to fees. The listing fee for a CAP ranges from $1,600 to $3,000, depending on the intended use of the color additive and the scope of the requested amendment. A complete schedule of fees is set forth in § 70.19. An average of one Category A and one Category B color additive petition is expected per year. The maximum CAP fee for a Category A petition is $2,600 and the maximum color additive petition fee for a Category B petition is $3,000. Because an average of 2 CAPs VerDate Sep<11>2014 19:55 Aug 24, 2020 Jkt 250001 are expected per calendar year, the estimated total annual cost burden to petitioners for this startup cost would be less than or equal to $5,600 ((1 × $2,600) + (1 × $3,000) listing fees = $5,600). There are no capital costs associated with CAPs. The labeling requirements for food and color additives were designed to specify the minimum information needed for labeling in order that food and color manufacturers may comply with all applicable provisions of the FD&C Act and other specific labeling acts administered by FDA. Label information does not require any additional information gathering beyond what is already required to assure conformance with all specifications and limitations in any given food or color additive regulation. Label information does not have any specific recordkeeping requirements unique to preparing the label. Therefore, because labeling requirements under § 70.25 for a particular color additive involve information required as part of the CAP safety review process, the estimate for number of respondents is the same for PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 §§ 70.25 and 71.1, and the burden hours for labeling are included in the estimate for § 71.1. Also, because labeling requirements under parts 172, 173, 179, and 180 for particular food additives involve information required as part of the FAP safety review process under § 171.1, the burden hours for labeling are included in the estimate for § 171.1. Dated: August 17, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–18602 Filed 8–24–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product Food and Drug Administration, Health and Human Service (HHS). ACTION: Notice. AGENCY: E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Pages 52353-52354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18602]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0908]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Submission of 
Petitions--Food Additive, Color Additive (Including Labeling), 
Submission of Information to a Master File in Support of Petitions; and 
Electronic Submission Using Food and Drug Administration Form 3503

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: Submit written comments (including recommendations) on the 
collection of information by September 24, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0016. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

Submission of Petitions: Food Additive, Color Additive (Including 
Labeling); Submission of Information to a Master File in Support of 
Petitions; Electronic Submission Using Form FDA 3503--21 CFR 70.25, 
71.1, 171.1, 172, 173, 179, and 180

OMB Control Number 0910-0016--Revision

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe, unless: (1) The additive and its use, or intended use, 
are in conformity with a regulation issued under section 409 that 
describes the condition(s) under which the additive may be safely used; 
(2) the additive and its use, or intended use, conform to the terms of 
an exemption for investigational use; or (3) a food contact 
notification submitted under section 409(h) of the FD&C Act is 
effective. Food additive petitions (FAPs) are submitted by individuals 
or companies to obtain approval of a new food additive or to amend the 
conditions of use permitted under an existing food additive regulation. 
Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the 
information that a petitioner must submit to establish that the 
proposed use of a food additive is safe and to secure the publication 
of a food additive regulation describing the conditions under which the 
additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts 
172, 173, 179, and 180) contain labeling requirements for certain food 
additives to ensure their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a 
color additive shall be deemed to be unsafe unless the additive and its 
use are in conformity with a regulation that describes the condition(s) 
under which the additive may safely be used, or the additive and its 
use conform to the terms of an exemption for investigational use issued 
under section 721(f) of the FD&C Act. Color additive petitions (CAPs) 
are submitted by individuals or companies to obtain approval of a new 
color additive or a change in the conditions of use permitted for a 
color additive that is already approved. Section 71.1 of the Agency's 
regulations (21 CFR 71.1) specifies the information that a petitioner 
must submit to establish the safety of a color additive and to secure 
the issuance of a regulation permitting its use. FDA's color additive 
labeling requirements in Sec.  70.25 (21 CFR 70.25) require that color 
additives that are to be used in food, drugs, devices, or cosmetics be 
labeled with sufficient information to ensure their safe use.
    FDA scientific personnel reviews FAPs to ensure the safety of the 
intended use of the additive in or on food, or that may be present in 
food as a result of its use in articles that contact food. Likewise, 
FDA personnel review CAPs to ensure the safety of the color

[[Page 52354]]

additive prior to its use in food, drugs, cosmetics, or medical 
devices.
    Respondents may transmit FAP or CAP regulatory submissions in 
electronic format or paper format to the Office of Food Additive Safety 
in the Center for Food Safety and Applied Nutrition (CFSAN) using Form 
FDA 3503. Form FDA 3503 helps the respondent organize their submission 
to focus on the information needed for FDA's safety review. Form FDA 
3503 can also be used to organize information within a master file 
submitted in support of petitions 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 the Agency, thus minimizing 
paperwork burden for food and color additive approvals. FDA estimates 
that the amount of time for respondents to complete Form FDA 3503 will 
continue to be 1 hour.
    We are revising the information collection to reflect ongoing 
modernization efforts. We have augmented our FDA Unified Registration 
and Listing System (FURLS) with the CFSAN Online Submission Module 
(COSM). COSM provides a real-time user interface process we believe 
will assist respondents in preparing and making submissions to Offices 
in CFSAN. COSM is a web-based tool that supports electronic 
submissions, thereby eliminating the need for printing and mailing of 
paper submissions. COSM is available 24 hours a day and seven days a 
week. Information submitted to COSM is the same information respondents 
would submit to FURLS. Information about COSM, including user 
instruction, is available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
    Description of Respondents: Respondents are businesses engaged in 
the manufacture or sale of food, food ingredients, color additives, or 
substances used in materials that come into contact with food.
    In the Federal Register of March 17, 2020 (85 FR 15188), we 
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
                  21 CFR section; form                      respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           CAP
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          FAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
Form FDA 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,959           5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Our estimate of burden attributable to FAPs or CAPs is based on our 
experience with the information collection, which has not changed since 
our last review, and we therefore retain the currently approved burden. 
This estimate reflects the average number of petitions we have received 
annually over a period of 10 years. The attendant burden we estimate 
also reflects an industry average, although burden associated with 
individual petitions may vary depending on the complexity of the 
petition, and the amount and type of data needed for scientific 
analysis.
    CAPs are subject to fees. The listing fee for a CAP ranges from 
$1,600 to $3,000, depending on the intended use of the color additive 
and the scope of the requested amendment. A complete schedule of fees 
is set forth in Sec.  70.19. An average of one Category A and one 
Category B color additive petition is expected per year. The maximum 
CAP fee for a Category A petition is $2,600 and the maximum color 
additive petition fee for a Category B petition is $3,000. Because an 
average of 2 CAPs are expected per calendar year, the estimated total 
annual cost burden to petitioners for this startup cost would be less 
than or equal to $5,600 ((1 x $2,600) + (1 x $3,000) listing fees = 
$5,600). There are no capital costs associated with CAPs. The labeling 
requirements for food and color additives were designed to specify the 
minimum information needed for labeling in order that food and color 
manufacturers may comply with all applicable provisions of the FD&C Act 
and other specific labeling acts administered by FDA. Label information 
does not require any additional information gathering beyond what is 
already required to assure conformance with all specifications and 
limitations in any given food or color additive regulation. Label 
information does not have any specific recordkeeping requirements 
unique to preparing the label. Therefore, because labeling requirements 
under Sec.  70.25 for a particular color additive involve information 
required as part of the CAP safety review process, the estimate for 
number of respondents is the same for Sec. Sec.  70.25 and 71.1, and 
the burden hours for labeling are included in the estimate for Sec.  
71.1. Also, because labeling requirements under parts 172, 173, 179, 
and 180 for particular food additives involve information required as 
part of the FAP safety review process under Sec.  171.1, the burden 
hours for labeling are included in the estimate for Sec.  171.1.

    Dated: August 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18602 Filed 8-24-20; 8:45 am]
BILLING CODE 4164-01-P

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