Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39793 

naturally occurring cases of diseases or 

conditions that are identified in the 

Centers for Disease Control and 

Prevention’s list of category ‘‘A’’ 

biological threat agents. The number of 

cases that would result from a terrorist 

event or other public health emergency 

is uncertain. Based on its knowledge of 

similar types of submissions, FDA 

estimates that it will take about 2 hours 

to prepare each certification. We 

estimate the operating and maintenance 

cost of $200 for copying and mailing the 

information to FDA. 

Based on its knowledge of similar 

types of submissions, FDA estimates 

that it will take about 1 hour to prepare 

a report disclosing the investigational 

status of the in vitro diagnostic device 

and what is known about the 

performance characteristics of the 

device and submit it to the health care 

provider and, where appropriate, to 

public health authorities. 

In the Federal Register of April 18, 

2017 (82 FR 18294), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Total 

operating and 

maintenance 

costs 

Written certification (sent to 

FDA)—50.23(e)(3).

150 3 450 0.25 (15 minutes) ............... 113 $200 

1There are no capital costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: August 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

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 oira_

submission@omb.eop.gov. 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, 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. 

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 


sradovich on DSK3GMQ082PROD with NOTICES
39794 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 

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 

§ 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

21 CFR section/FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating and 

maintenance 

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 

1There 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 § 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 

§§ 70.25 and 71.1, and the burden hours 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39795 

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, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary 

Cosmetic Registration Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 

(PRA). 

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 oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0027. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A63, 11601 Landsdown 

St., North Bethesda, MD 20852, 301– 

796–7726, 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. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

OMB Control Number 0910–0027— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides us with the 

authority to regulate cosmetic products 

in the United States. Cosmetic products 

that are adulterated under section 601 of 

the FD&C Act (21 U.S.C. 361) or 

misbranded under section 602 of the 

FD&C Act (21 U.S.C. 362) may not be 

distributed in interstate commerce. We 

have developed the Voluntary Cosmetic 

Registration Program (VCRP) to assist us 

in carrying out our responsibility to 

regulate cosmetics. 

FDA is revising forms for the VCRP 

(Forms FDA 2511, 2512, 2512a, and 

2514) currently approved under OMB 

control number 0910–0027, ‘‘Voluntary 

Cosmetic Registration Program,’’ for the 

following reasons: (1) Modernizing the 

forms; (2) Making it easier for filers who 

complete the forms; and (3) reducing the 

time it will take FDA to review each 

submission. In addition, Form FDA 

2514 will be eliminated as it duplicates 

information that is currently located on 

Form FDA 2512. FDA requests PRA 

approval for the proposed changes to 

these forms, and for the elimination of 

Form FDA 2514. 

Participation in the VCRP is voluntary 

under provisions found in sections parts 

710 and 720 (21 CFR parts 710 and 720). 

Participants have the option of 

submitting information via paper forms 

or via the online interface. The term 

‘‘form’’ refers to both the paper form and 

the online system. 

Currently, in part 710, we request that 

establishments that manufacture or 

package cosmetic products voluntarily 

register with us using Form FDA 2511 

entitled ‘‘Registration of Cosmetic 

Product Establishment.’’ The online 

version of Form FDA 2511 is available 

on our VCRP Web site at https://

www.fda.gov/Cosmetics/Registration

Program/default.htm. We strongly 

encourage online registration with Form 

FDA 2511 because it is faster and more 

efficient for the filer and the Agency. A 

registering facility will receive 

confirmation of online registration, 

including a registration number by 

email. The online system also allows for 

amendments to past submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. We 

place the registration information in a 

computer database and use the 

information to generate lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. Registration is permanent, 

although we request that respondents 

submit an amended Form FDA 2511 if 

any of the originally submitted 

information changes. 

FDA’s proposed changes to the forms 

through the use of an electronic 

submission system have been designed 

to make it easier for participants to 

provide information to FDA about their 

products. The system also assists 

participants, through interactive 

question and response scenarios, to 

identify submissions that will be 

ineligible to be accepted in VCRP 

because they do not meet parts 710 and 

720 requirements. The electronic 

submission system is expected to reduce 

burden currently associated with the 

manual identification process for filers 

and FDA. The rejection rate for 

ineligible submissions when using the 

current forms is high: 51 percent for 

new accounts, 43 percent for Form FDA 

2511 registrations, and 7 percent for 

Form FDA 2512 filings (2010–2016). 

The revised forms include the 

addition of links between Forms FDA 

2511 and 2512, clarification of what 

information should be entered onto the 

forms, additional self-identifying fields, 

removal of certain duplicative fields, 

and the deletion of Form FDA 2514. 

These changes are needed because both 

VCRP voluntary filer participation and 

FDA resources required to administer 

VCRP have increased significantly since 

2014 (i.e., increases in new accounts 

(156 percent), Form FDA 2511 

registrations (405 percent), Form FDA 

2512 filings (67 percent), and FDA 

review hours (59 percent) in 2016.) 

FDA’s current process confirms that 

each submission meets the requirements 

established in parts 710 and 720 by 

using a manual process for both filers 

and FDA reviewers that may result in a 

long waiting period where filers must 

wait and respond to questions generated 

by FDA, which may result in a high 

rejection rate. FDA projects a significant 

reduction in rejection rates when using 

the revised forms. Examples of possible 

burden savings for participants and FDA 

include: 

(1) Form FDA 2511 asks filers if they 

are a manufacturer or packer; however, 

in the past, distributors and retailers 

have checked these boxes in error when 

neither applies to them because there 

are no distributor or retailer checkboxes 

on Form FDA 2511. Retailers have also 

filed Form FDA 2512 in error even 

though only manufacturers, packers, 


sradovich on DSK3GMQ082PROD with NOTICES