80_FR_17507 80 FR 17445 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives

80 FR 17445 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 62 (April 1, 2015)

Page Range17445-17446
FR Document2015-07420

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 solicits comments on burden hours associated with the animal food industry declaring the presence of certified and noncertified color additives in their animal food products on the animal food label.

Federal Register, Volume 80 Issue 62 (Wednesday, April 1, 2015) 
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17445-17446]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07420]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0025]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Food Labeling; Declaration of Certifiable Color 
Additives

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. 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 solicits comments on burden hours associated with 
the animal food industry declaring the presence of certified and 
noncertified color additives in their animal food products on the 
animal food label.

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: 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: 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,

[[Page 17446]]

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, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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.

Animal Food Labeling; Declaration of Certifiable Color Additives--21 
CFR 501.22(k) (OMB Control Number 0910-0721--Extension)

    This information collection is associated with requirements under 
Sec.  501.22(k) (21 CFR 501.22(k)) in which animal food manufacturers 
must declare the presence of certified and noncertified color additives 
in their animal food products on the product label. The Agency issued 
this regulation in response to the Nutrition Labeling and Education Act 
of 1990 to make animal food regulations consistent with the regulations 
regarding the declaration of color additives on human food labels and 
to provide animal owners with information on the colors used in animal 
food.
    Respondents to this collection are manufacturers of pet food that 
contain color additives. Manufacturers of certain food or food 
ingredients do not have products that contain color additives requiring 
certification (e.g., food for chickens, fish, and some other species, 
including some pet foods) and would thus be minimally affected by Sec.  
501.22(k)(1). However, since we cannot rule out the possibility that 
they may at some point use a color additive requiring certification, we 
have consolidated the burden estimates for Sec.  501.22(k)(1) and 
(k)(2). Additionally, we believe that this burden is more accurately 
characterized as a third-party disclosure burden because FDA does not 
require routine submission of pet food labeling to the Agency.
    FDA estimates the burden for this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR Section; activity                          Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
501.22(k); labeling of color additive or lake of color additive;              3,120             0.83            2,587             0.25              647
 labeling of color additives not subject to certification..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Because Sec.  501.22(k) became effective November 18, 2013, the 
Agency estimates that the burden associated with the labeling 
requirements under Sec.  501.22(k) applies only to new product labels. 
Because the vast majority of animal food products that contain 
certified color additives are pet foods, we limit our burden estimate 
to reviewing labels for the use of certified color additives to pet 
food manufacturers subject to this regulation.
    Based on A.C. Nielsen Data, FDA estimates that the number of animal 
food product units subject to Sec.  501.22(k) for which sales of the 
products are greater than zero is 25,874. Assuming that the flow of new 
products is 10 percent per year, then 2,587 new animal food products 
subject to Sec.  501.22(k) will come on the market each year. FDA also 
estimates that there are about 3,120 manufacturers of pet food subject 
to either Sec.  501.22(k)(1) or (k)(2). Assuming the approximately 
2,587 new products are split equally among the firms, then each firm 
would prepare labels for approximately 0.83 new products per year 
(2,587 new products/3,120 firms is approximately 0.83 labels per firm).
    The Agency expects that firms prepare the required labeling for 
their products in a manner that takes into account at one time all 
information required to be disclosed on their product labels. Based on 
our experience with reviewing pet food labeling, FDA estimates that 
firms would require less than 0.25 hour (15 minutes) per product to 
comply with the requirement to include the color additive information 
under Sec.  501.22(k). The total burden of this activity is 647 hours 
(2,587 labels x 0.25 hour/label is approximately 647 hours).

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07420 Filed 3-31-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17445 Please ensure that your comments are DEPARTMENT OF HEALTH AND the proposed information collection are submitted within the specified HUMAN SERVICES being solicited. nomination period. Nominations This request is for approval of a plan received after the closing date will be Administration for Children and for conducting more than one marked as late and may be considered Families information collection that is very only if time and resources permit. similar, voluntary, low-burden and Submission for OMB Review; uncontroversial. Information collections Sascha Chaney, Comment Request under this generic clearance will be in Acting Director, Office of Policy, Planning compliance with U.S. Department of and Evaluation National Center for Title: Generic Clearance for Grant Health and Humans Services’ Grants Environmental Health/Agency for Toxic Reviewer Recruitment Form. Policy Directive 2.04 ‘‘Awarding Substances and Disease Registry. OMB No.: New. Grants’’, and the Awarding Agency [FR Doc. 2015–07437 Filed 3–31–15; 8:45 am] Description: This notice announces Grants Administration Manual, Chapter BILLING CODE 4163–70–P that the Administration for Children 2.04C ‘‘Objective Review of Grant and Families intends to submit the Applications. These forms will be used proposed Information Collection to select reviewers who will participate Request (Generic ICR): Generic in the grant review process for the Clearance for Grant Reviewer purpose of selecting successful Application Form under the Paperwork applications. Reduction (PRA) (44 U.S.C. 3501 et. Respondents: Grant Reviewer seq.). Comments on specific aspects for Candidates. ANNUAL BURDEN ESTIMATES Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response Recruitment Form ............................................................................................ 1,500 1 0.5 750 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND ADDRESSES: Submit electronic Hours: 750 Hours. HUMAN SERVICES comments on the collection of Additional Information: Copies of the information to http:// Food and Drug Administration www.regulations.gov. Submit written proposed collection may be obtained by writing to the Administration for [Docket No. FDA–2009–N–0025] comments on the collection of information to the Division of Dockets Children and Families, Office of Agency Information Collection Management (HFA–305), Food and Drug Planning, Research and Evaluation, 370 Activities; Proposed Collection; Administration, 5630 Fishers Lane, Rm. L’Enfant Promenade SW., Washington, 1061, Rockville, MD 20852. All Comment Request; Animal Food DC 20447, Attn: ACF Reports Clearance comments should be identified with the Labeling; Declaration of Certifiable Officer. All requests should be docket number found in brackets in the Color Additives identified by the title of the information heading of this document. collection. Email address: AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA infocollection@acf.hhs.gov. HHS. PRA Staff, Office of Operations, Food OMB Comment: OMB is required to ACTION: Notice. and Drug Administration, 8455 make a decision concerning the Colesville Rd., COLE–14526, Silver SUMMARY: The Food and Drug collection of information between 30 Spring, MD 20993–0002, PRAStaff@ Administration (FDA) is announcing an and 60 days after publication of this fda.hhs.gov. opportunity for public comment on the document in the Federal Register. proposed collection of certain Therefore, a comment is best assured of SUPPLEMENTARY INFORMATION: Under the information by the Agency. Under the PRA (44 U.S.C. 3501–3520), Federal having its full effect if OMB receives it Paperwork Reduction Act of 1995 (the Agencies must obtain approval from the within 30 days of publication. Written PRA), Federal Agencies are required to Office of Management and Budget comments and recommendations for the publish notice in the Federal Register (OMB) for each collection of proposed information collection should concerning each proposed collection of information they conduct or sponsor. be sent directly to the following: Office information, including each proposed ‘‘Collection of information’’ is defined of Management and Budget, Paperwork extension of an existing collection of in 44 U.S.C. 3502(3) and 5 CFR Reduction Project, Email: OIRA_ information, and to allow 60 days for 1320.3(c) and includes Agency requests SUBMISSION@OMB.EOP.GOV, Attn: public comment in response to the or requirements that members of the Desk Officer for the Administration for notice. This notice solicits comments on public submit reports, keep records, or Children and Families. burden hours associated with the mstockstill on DSK4VPTVN1PROD with NOTICES provide information to a third party. animal food industry declaring the Section 3506(c)(2)(A) of the PRA (44 Robert Sargis, presence of certified and noncertified U.S.C. 3506(c)(2)(A)) requires Federal Reports Clearance Officer. color additives in their animal food Agencies to provide a 60-day notice in [FR Doc. 2015–07352 Filed 3–31–15; 8:45 am] products on the animal food label. the Federal Register concerning each BILLING CODE 4184–01–P DATES: Submit either electronic or proposed collection of information, written comments on the collection of including each proposed extension of an information by June 1, 2015. existing collection of information, VerDate Sep<11>2014 18:37 Mar 31, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1

17446 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices before submitting the collection to OMB when appropriate, and other forms of Respondents to this collection are for approval. To comply with this information technology. manufacturers of pet food that contain requirement, FDA is publishing notice color additives. Manufacturers of certain Animal Food Labeling; Declaration of of the proposed collection of food or food ingredients do not have Certifiable Color Additives—21 CFR information set forth in this document. products that contain color additives With respect to the following 501.22(k) (OMB Control Number 0910– 0721—Extension) requiring certification (e.g., food for collection of information, FDA invites chickens, fish, and some other species, comments on these topics: (1) Whether This information collection is including some pet foods) and would the proposed collection of information associated with requirements under thus be minimally affected by is necessary for the proper performance § 501.22(k) (21 CFR 501.22(k)) in which § 501.22(k)(1). However, since we of FDA’s functions, including whether animal food manufacturers must declare cannot rule out the possibility that they the information will have practical the presence of certified and may at some point use a color additive utility; (2) the accuracy of FDA’s noncertified color additives in their requiring certification, we have estimate of the burden of the proposed animal food products on the product consolidated the burden estimates for collection of information, including the label. The Agency issued this regulation validity of the methodology and in response to the Nutrition Labeling § 501.22(k)(1) and (k)(2). Additionally, assumptions used; (3) ways to enhance and Education Act of 1990 to make we believe that this burden is more the quality, utility, and clarity of the animal food regulations consistent with accurately characterized as a third-party information to be collected; and (4) the regulations regarding the declaration disclosure burden because FDA does ways to minimize the burden of the of color additives on human food labels not require routine submission of pet collection of information on and to provide animal owners with food labeling to the Agency. respondents, including through the use information on the colors used in FDA estimates the burden for this of automated collection techniques, animal food. collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR Section; activity burden per Total hours respondents per respond- disclosures disclosure ent 501.22(k); labeling of color additive or lake of color addi- tive; labeling of color additives not subject to certification 3,120 0.83 2,587 0.25 647 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Because § 501.22(k) became effective account at one time all information provisions set forth in sections November 18, 2013, the Agency required to be disclosed on their 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., estimates that the burden associated product labels. Based on our experience as amended. The grant applications and with the labeling requirements under with reviewing pet food labeling, FDA the discussions could disclose § 501.22(k) applies only to new product estimates that firms would require less confidential trade secrets or commercial labels. Because the vast majority of than 0.25 hour (15 minutes) per product property such as patentable material, animal food products that contain to comply with the requirement to and personal information concerning certified color additives are pet foods, include the color additive information individuals associated with the grant we limit our burden estimate to under § 501.22(k). The total burden of applications, the disclosure of which reviewing labels for the use of certified this activity is 647 hours (2,587 labels would constitute a clearly unwarranted color additives to pet food x 0.25 hour/label is approximately 647 invasion of personal privacy. manufacturers subject to this regulation. hours). Name of Committee: National Institute on Based on A.C. Nielsen Data, FDA Dated: March 25, 2015. Alcohol Abuse and Alcoholism Special estimates that the number of animal Leslie Kux, Emphasis Panel; Review of Alcohol Health food product units subject to § 501.22(k) Disparity Research Centers. Associate Commissioner for Policy. for which sales of the products are Date: April 28, 2015. [FR Doc. 2015–07420 Filed 3–31–15; 8:45 am] Time: 1:00 p.m. to 5:00 p.m. greater than zero is 25,874. Assuming BILLING CODE 4164–01–P Agenda: To review and evaluate grant that the flow of new products is 10 applications. percent per year, then 2,587 new animal Place: NIAAA, NIH, 5635 Fishers Lane, food products subject to § 501.22(k) will DEPARTMENT OF HEALTH AND Rockville, MD 20852, (Telephone Conference come on the market each year. FDA also HUMAN SERVICES Call). estimates that there are about 3,120 Contact Person: Ranga Srinivas, Ph.D., manufacturers of pet food subject to National Institutes of Health Chief, Extramural Project Review Branch, either § 501.22(k)(1) or (k)(2). Assuming National Institute on Alcohol Abuse and the approximately 2,587 new products National Institute on Alcohol Abuse Alcoholism, NIH, 5635 Fishers Lane, Room are split equally among the firms, then and Alcoholism; Notice of Closed 2085, Rockville, MD 20852, (301) 443–2067, mstockstill on DSK4VPTVN1PROD with NOTICES Meeting srinivar@mail.nih.gov. each firm would prepare labels for approximately 0.83 new products per (Catalogue of Federal Domestic Assistance Pursuant to section 10(d) of the Program Nos. 93.271, Alcohol Research year (2,587 new products/3,120 firms is Federal Advisory Committee Act, as approximately 0.83 labels per firm). Career Development Awards for Scientists amended (5 U.S.C. App.), notice is and Clinicians; 93.272, Alcohol National The Agency expects that firms hereby given of the following meeting. Research Service Awards for Research prepare the required labeling for their The meeting will be closed to the Training; 92.273, Alcohol Research Programs; products in a manner that takes into public in accordance with the 93.891, Alcohol Research Center Grants; VerDate Sep<11>2014 18:37 Mar 31, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1


Document Created: 2015-12-18 11:04:31
Document Modified: 2015-12-18 11:04:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by June 1, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 17445 
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