82 FR 39793 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 161 (August 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 161 (August 22, 2017)
| Page Range | 39793-39795 | |
| FR Document | 2017-17703 |
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)] [Notices] [Pages 39793-39795] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17703] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0258] 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: Fax written comments on the collection of information by September 21, 2017. 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 [email protected]. All comments should be identified with the OMB control number 0910-0016 and title ``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.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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; and Electronic Submission Using Food and Drug Administration Form 3503--21 CFR 70.25, 71.1, and 171.1, and 21 CFR parts 172, 173, 179, and 180; OMB Control Number 0910-0016--Extension. Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 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 of the FD&C Act 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) 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 [[Page 39794]] 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). 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, medical devices, or cosmetics be labeled with sufficient information to ensure their safe use. FDA scientific personnel review 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 additive prior to its use in food, drugs, medical devices, or cosmetics. Interested persons 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 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. 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 May 30, 2017 (82 FR 24718), 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average operating and 21 CFR section/FDA form respondents responses per responses burden per Total hours maintenance respondent response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Color Additive Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- 70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600 -------------------------------------------------------------------------------------------------------------------------------------------------------- Food Additive Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- 171.1................................................... 3 1 3 7,093 21,279 0 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Form 3503........................................... 6 1 6 1 6 0 ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. 23,959 5,600 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. The estimate of burden for food additive or color additive petitions is based on FDA's experience with the petition process. The burden for this information collection has changed since the last OMB approval because the Generally Recognized as Safe affirmations have been removed pursuant to the implementation of ``Substances Generally Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior estimate of the number of petitions received because the average number of petitions received annually has varied little over the past 10 years. The figures for hours per response are based on estimates from experienced persons in the Agency and in industry. Although the estimated hour burden varies with the type of petition submitted, an average petition involves analytical work and appropriate toxicological studies, as well as the work of drafting the petition itself. The burden varies depending on the complexity of the petition, including the amount and types of data needed for scientific analysis. Color additives are subjected to payment of fees for the petitioning process. The listing fee for a color additive petition ranges from $1,600 to $3,000, depending on the intended use of the color additive and the scope of 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. Labeling 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. Labeling 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 [[Page 39795]] 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, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17703 Filed 8-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39793
naturally occurring cases of diseases or estimate the operating and maintenance provider and, where appropriate, to
conditions that are identified in the cost of $200 for copying and mailing the public health authorities.
Centers for Disease Control and information to FDA. In the Federal Register of April 18,
Prevention’s list of category ‘‘A’’ Based on its knowledge of similar
2017 (82 FR 18294), FDA published a
biological threat agents. The number of types of submissions, FDA estimates
60-day notice requesting public
cases that would result from a terrorist that it will take about 1 hour to prepare
comment on the proposed collection of
event or other public health emergency a report disclosing the investigational
is uncertain. Based on its knowledge of status of the in vitro diagnostic device information. No comments were
similar types of submissions, FDA and what is known about the received.
estimates that it will take about 2 hours performance characteristics of the FDA estimates the burden of this
to prepare each certification. We device and submit it to the health care collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
Number of
Number of Total annual Average burden per operating and
21 CFR section responses per Total hours
respondents responses response maintenance
respondent costs
Written certification (sent to 150 3 450 0.25 (15 minutes) ............... 113 $200
FDA)—50.23(e)(3).
1 There are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Part burden per Total hours
respondents per disclosures disclosure
respondent
Written certification (sent to IRB)—50.23(e)(1) and (2) ...... 150 3 450 2 900
Informed consent information—50.23(e)(4) ......................... 150 3 450 1 450
Total .............................................................................. ........................ ........................ ........................ ........................ 1,350
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 17, 2017. (OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In
Leslie Kux, the Paperwork Reduction Act of 1995. compliance with 44 U.S.C. 3507, FDA
Associate Commissioner for Policy. has submitted the following proposed
DATES: Fax written comments on the collection of information to OMB for
[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am]
collection of information by September review and clearance.
BILLING CODE 4164–01–P
21, 2017.
Submission of Petitions: Food
ADDRESSES: To ensure that comments on Additive, Color Additive (Including
DEPARTMENT OF HEALTH AND the information collection are received, Labeling), Submission of Information to
HUMAN SERVICES OMB recommends that written a Master File in Support of Petitions;
comments be faxed to the Office of and Electronic Submission Using Food
Food and Drug Administration Information and Regulatory Affairs, and Drug Administration Form 3503—
OMB, Attn: FDA Desk Officer, Fax: 202– 21 CFR 70.25, 71.1, and 171.1, and 21
[Docket No. FDA–2010–N–0258] CFR parts 172, 173, 179, and 180; OMB
395–7285, or emailed to oira_
submission@omb.eop.gov. All Control Number 0910–0016—Extension.
Agency Information Collection
comments should be identified with the Section 409(a) of the Federal Food,
Activities; Submission for Office of
OMB control number 0910–0016 and Drug, and Cosmetic Act (the FD&C Act)
Management and Budget Review;
title ‘‘Submission of Petitions: Food (21 U.S.C. 348(a)) provides that a food
Comment Request; Submission of
Additive, Color Additive (Including additive shall be deemed to be unsafe,
Petitions: Food Additive, Color
Labeling), Submission of Information to unless: (1) The additive and its use, or
Additive (Including Labeling),
a Master File in Support of Petitions; intended use, are in conformity with a
Submission of Information to a Master
and Electronic Submission Using Food regulation issued under section 409 of
File in Support of Petitions; and
and Drug Administration Form 3503.’’ the FD&C Act that describes the
Electronic Submission Using Food and
Also include the FDA docket number condition(s) under which the additive
Drug Administration Form 3503
found in brackets in the heading of this may be safely used; (2) the additive and
AGENCY: Food and Drug Administration, document. its use, or intended use, conform to the
terms of an exemption for
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Ila investigational use; or (3) a food contact
Mizrachi, Office of Operations, Food notification submitted under section
SUMMARY: The Food and Drug and Drug Administration, Three White 409(h) is effective. Food additive
Administration (FDA) is announcing Flint North, 10A–12M, 11601 petitions (FAPs) are submitted by
that a proposed collection of Landsdown St., North Bethesda, MD individuals or companies to obtain
information has been submitted to the 20852, 301–796–7726, PRAStaff@ approval of a new food additive or to
Office of Management and Budget fda.hhs.gov. amend the conditions of use permitted
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![Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39795
for labeling are included in the estimate Voluntary Cosmetic Registration computer database and use the
for § 71.1. Also, because labeling Program—21 CFR Parts 710 and 720 information to generate lists for
requirements under parts 172, 173, 179, OMB Control Number 0910–0027— distributing regulatory information and
and 180 for particular food additives Extension for inviting firms to participate in
involve information required as part of workshops on topics in which they may
the FAP safety review process under The Federal Food, Drug, and Cosmetic be interested. Registration is permanent,
§ 171.1, the burden hours for labeling Act (the FD&C Act) provides us with the although we request that respondents
are included in the estimate for § 171.1. authority to regulate cosmetic products submit an amended Form FDA 2511 if
in the United States. Cosmetic products any of the originally submitted
Dated: August 17, 2017. that are adulterated under section 601 of information changes.
Leslie Kux, the FD&C Act (21 U.S.C. 361) or FDA’s proposed changes to the forms
Associate Commissioner for Policy. misbranded under section 602 of the through the use of an electronic
[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am] FD&C Act (21 U.S.C. 362) may not be submission system have been designed
BILLING CODE 4164–01–P distributed in interstate commerce. We to make it easier for participants to
have developed the Voluntary Cosmetic provide information to FDA about their
Registration Program (VCRP) to assist us products. The system also assists
DEPARTMENT OF HEALTH AND in carrying out our responsibility to participants, through interactive
HUMAN SERVICES regulate cosmetics. question and response scenarios, to
FDA is revising forms for the VCRP identify submissions that will be
Food and Drug Administration (Forms FDA 2511, 2512, 2512a, and ineligible to be accepted in VCRP
2514) currently approved under OMB because they do not meet parts 710 and
[Docket No. FDA–2010–N–0623] control number 0910–0027, ‘‘Voluntary 720 requirements. The electronic
Cosmetic Registration Program,’’ for the submission system is expected to reduce
Agency Information Collection following reasons: (1) Modernizing the burden currently associated with the
Activities; Submission for Office of forms; (2) Making it easier for filers who manual identification process for filers
Management and Budget Review; complete the forms; and (3) reducing the and FDA. The rejection rate for
Comment Request; Voluntary time it will take FDA to review each ineligible submissions when using the
Cosmetic Registration Program submission. In addition, Form FDA current forms is high: 51 percent for
2514 will be eliminated as it duplicates new accounts, 43 percent for Form FDA
AGENCY: Food and Drug Administration, information that is currently located on
HHS. 2511 registrations, and 7 percent for
Form FDA 2512. FDA requests PRA Form FDA 2512 filings (2010–2016).
ACTION: Notice. approval for the proposed changes to The revised forms include the
these forms, and for the elimination of addition of links between Forms FDA
SUMMARY: The Food and Drug
Form FDA 2514. 2511 and 2512, clarification of what
Administration (FDA, Agency, or we) is Participation in the VCRP is voluntary
announcing that a proposed collection information should be entered onto the
under provisions found in sections parts forms, additional self-identifying fields,
of information has been submitted to the 710 and 720 (21 CFR parts 710 and 720). removal of certain duplicative fields,
Office of Management and Budget Participants have the option of and the deletion of Form FDA 2514.
(OMB) for review and clearance under submitting information via paper forms These changes are needed because both
the Paperwork Reduction Act of 1995 or via the online interface. The term VCRP voluntary filer participation and
(PRA). ‘‘form’’ refers to both the paper form and FDA resources required to administer
DATES: Fax written comments on the the online system. VCRP have increased significantly since
collection of information by September Currently, in part 710, we request that 2014 (i.e., increases in new accounts
21, 2017. establishments that manufacture or (156 percent), Form FDA 2511
ADDRESSES: To ensure that comments on package cosmetic products voluntarily registrations (405 percent), Form FDA
the information collection are received, register with us using Form FDA 2511 2512 filings (67 percent), and FDA
OMB recommends that written entitled ‘‘Registration of Cosmetic review hours (59 percent) in 2016.)
comments be faxed to the Office of Product Establishment.’’ The online FDA’s current process confirms that
Information and Regulatory Affairs, version of Form FDA 2511 is available each submission meets the requirements
OMB, Attn: FDA Desk Officer, Fax: 202– on our VCRP Web site at https:// established in parts 710 and 720 by
395–7285, or emailed to oira_ www.fda.gov/Cosmetics/Registration using a manual process for both filers
submission@omb.eop.gov. All Program/default.htm. We strongly and FDA reviewers that may result in a
comments should be identified with the encourage online registration with Form long waiting period where filers must
OMB control number 0910–0027. Also FDA 2511 because it is faster and more wait and respond to questions generated
include the FDA docket number found efficient for the filer and the Agency. A by FDA, which may result in a high
in brackets in the heading of this registering facility will receive rejection rate. FDA projects a significant
document. confirmation of online registration, reduction in rejection rates when using
including a registration number by the revised forms. Examples of possible
FOR FURTHER INFORMATION CONTACT: Ila email. The online system also allows for burden savings for participants and FDA
S. Mizrachi, Office of Operations, Food amendments to past submissions. include:
and Drug Administration, Three White Because registration of cosmetic (1) Form FDA 2511 asks filers if they
Flint North, 10A63, 11601 Landsdown product establishments is not are a manufacturer or packer; however,
sradovich on DSK3GMQ082PROD with NOTICES
St., North Bethesda, MD 20852, 301– mandatory, voluntary registration in the past, distributors and retailers
796–7726, PRAStaff@fda.hhs.gov. provides FDA with the best information have checked these boxes in error when
SUPPLEMENTARY INFORMATION: In available about the locations, business neither applies to them because there
compliance with 44 U.S.C. 3507, FDA trade names, and types of activity are no distributor or retailer checkboxes
has submitted the following proposed (manufacturing or packaging) of on Form FDA 2511. Retailers have also
collection of information to OMB for cosmetic product establishments. We filed Form FDA 2512 in error even
review and clearance. place the registration information in a though only manufacturers, packers,
VerDate Sep<11>2014 18:00 Aug 21, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/82_FR_39954/page/3.svg)
Document Created: 2018-10-24 11:56:34
Document Modified: 2018-10-24 11:56:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 21, 2017. | |
| Contact | Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 39793 |
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